FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients adding vildagliptin had a fall in HbA1c levels of 0.88 percentage points after 24 weeks from a starting level of 8.38%.
Danish: Patienter, som fik suppleret med vildagliptin, havde et fald i HbA1c-niveauerne på 0,88 procent efter 24 uger fra et udgangsniveau på 8,38 %.
English: Zomarist is a medicine that contains the active substances vildagliptin and metformin hydrochloride.
Danish: Zomarist er et lægemiddel, der indeholder de to aktive stoffer vildagliptin og metforminhydrochlorid.
English: It must also not be used in patients with alcohol intoxication (excessive alcohol consumption) or alcoholism, or during breastfeeding.
Danish: Det må heller ikke gives til patienter med alkoholforgiftning (overdrevet alkoholforbrug) eller alkoholisme eller til ammende kvinder.
English: The most common side effects with Zomarist (seen in more than 1 patient in 10) are nausea (feeling sick), vomiting, diarrhoea, abdominal (tummy) pain and loss of appetite.
Danish: De hyppigste bivirkninger ved Zomarist (som ses hos flere end 1 ud af 10 patienter) er kvalme, opkastning og diarré, mavesmerter og appetitløshed.
English: Zomarist should not be used in people who may be hypersensitive (allergic) to vildagliptin, metformin or any of the other ingredients.
Danish: Zomarist bør ikke anvendes til personer, som kan være overfølsomme (allergiske) over for vildagliptin, metformin eller et af de øvrige indholdsstoffer.
English: What is the risk associated with Zomarist?
Danish: Hvilken risiko er der forbundet med Zomarist ?
English: Why has Zomarist been approved?
Danish: Hvorfor blev Zomarist godkendt?
English: The studies with Galvus as an add-on to metformin, metformin and a sulphonylurea, or metformin and insulin have been used to support the use of Zomarist in the same indications.
Danish: Undersøgelserne af Galvus som tillægsbehandling til metformin, metformin og et sulfonylurinstof eller metformin og insulin blev anvendt til at underbygge brugen af Zomarist til samme indikationer.
English: For the full list of all side effects reported with Zomarist, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Zomarist fremgår af indlægssedlen.
English: In other studies, vildagliptin in combination with metformin has been shown to be more effective than placebo when used with a sulphonylurea or insulin.
Danish: I andre undersøgelser viste vildagliptin i kombination med metformin sig at være mere effektivt end placebo, når det blev anvendt sammen med et sulfonylurinstof eller insulin.
English: • in combination with insulin together with diet and exercise, in patients whose diabetes is insufficiently controlled with insulin at a stable dose and metformin.
Danish: • i kombination med insulin sammen med diæt og motion til patienter, hvis diabetes ikke er tilstrækkeligt kontrolleret med en fast dosis insulin og metformin.
English: What is Zomarist?
Danish: Hvad er Zomarist?
English: • in combination with a sulphonylurea (another type of anti-diabetes medicine) together with diet and exercise, in patients whose diabetes is not satisfactorily controlled on metformin and a sulphonylurea;
Danish: • i kombination med et sulfonylurinstof (en anden type lægemiddel mod diabetes) og sammen med diæt og motion til patienter, der ikke er tilstrækkeligt kontrolleret med metformin og et sulfonylurinstof,
English: Zomarist should not be used in patients who have moderate or severe problems with their kidneys or who have problems with their liver.
Danish: Zomarist bør ikke anvendes til patienter, der lider af moderat til svære nyre- eller leverproblemer.
English: What is Zomarist used for?
Danish: Hvad anvendes Zomarist til?
English: How has Zomarist been studied?
Danish: Hvordan blev Zomarist undersøgt?
English: How is Zomarist used?
Danish: Hvordan anvendes Zomarist?
English: What benefit has Zomarist shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Zomarist?
English: How does Zomarist work?
Danish: Hvordan virker Zomarist?
English: List of antiretrovirals: abacavir; abacavir, dolutegravir, lamivudine; abacavir; abacavir, lamivudine, zidovudine; atazanavir; atazanavir, cobicistat; bictegravir, emtricitabine, tenofovir alafenamide; darunavir; darunavir, cobicistat; darunavir, cobicistat, emtricitabine, tenofovir alafenamide; didanosine; dolutegravir; dolutegravir, rilpivirine; efavirenz ; efavirenz, emtricitabine, tenofovir disoproxil; elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide; elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil; emtricitabine; emtricitabine, rilpivirine, tenofovir alafenamide; emtricitabine, rilpivirine, tenofovir disoproxil; emtricitabine, tenofovir alafenamide; emtricitabine, tenofovir disoproxil; enfuvirtide; etravirine; fosamprenavir; indinavir; lamivudine; lamivudine, tenofovir; lamivudine, zidovudine; lopinavir, ritonavir; maraviroc; nevirapine; raltegravir; rilpivirine; ritonavir; saquinavir; stavudine; tenofovir disoproxil; tipranavir; zidovudine
Danish: Liste over antiretrovirale lægemidler: abacavir; abacavir, dolutegravir, lamivudin; abacavir; abacavir, lamivudin, zidovudin; atazanavir; atazanavir, cobicistat; bictegravir, emtricitabin, tenofoviralafenamid; darunavir; darunavir, cobicistat; darunavir, cobicistat, emtricitabin, tenofoviralafenamid; didanosin; dolutegravir; dolutegravir, rilpivirin; efavirenz; efavirenz, emtricitabin, tenofovirdisoproxil; elvitegravir, cobicistat, emtricitabin, tenofoviralafenamid; elvitegravir, cobicistat, emtricitabin, tenofovirdisoproxil; emtricitabin; emtricitabin, rilpivirin, tenofoviralafenamid; emtricitabin, rilpivirin, tenofovirdisoproxil; emtricitabin, tenofoviralafenamid; emtricitabin, tenofovirdisoproxil; enfuvirtid; etravirin; fosamprenavir; indinavir; lamivudin; lamivudin, tenofovir; lamivudin, zidovudin; lopinavir, ritonavir; maraviroc; nevirapin; raltegravir; rilpivirin; ritonavir; saquinavir; stavudin; tenofovirdisoproxil; tipranavir; zidovudin
English: Antiretrovirals - Autoimmune hepatitis (EPITT no 18956)
Danish: Antiretrovirale lægemidler - autoimmun hepatitis (EPITT nr. 18956)
English: Adopted at the 9-12 July 2018 PRAC
Danish: Vedtaget på PRAC's møde 9.-12. juli 2018
English: Human normal immunoglobulin for intravenous administration (IVIg) - Lupus-like syndrome and related terms (EPITT no 19098)
Danish: Humant normalt immunglobulin til intravenøs administration (IVIg)- lupus-lignende syndrom og relaterede termer (EPITT nr. 19098)
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis jirovecii pneumonia.
Danish: Relevante eksempler omfatter cytomegalovirus retinitis, generaliserede og/eller fokale mycobakterielle infektioner og pneumocystis jirovecii-pneumoni.
English: New product information wording - Extracts from PRAC recommendations on signals EMA/PRAC/414649/2018
Danish: Ny ordlyd af produktinformation - uddrag af PRAC's anbefalinger vedrørende signaler EMA/PRAC/496958/2018
English: Special warnings and precautions for use
Danish: Særlige advarsler og forsigtighedsregler vedrørende brugen Immunreaktiveringssyndrom
English: Cases of reversible aseptic meningitis and rare cases of transient cutaneous reactions (including cutaneous lupus erythematosus - frequency unknown) have been observed with human normal immunoglobulin.
Danish: Der er set tilfælde af reversibel aseptisk meningitis og sjældne tilfælde af forbigående hudreaktioner (herunder kutan lupus erythematosus - hyppighed ikke kendt) ved behandling med humant normalt immunglobulin.
English: In HIV infected patients with severe immune deficiency at the time of initiation of CART, an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
Danish: Hos hivinficerede patienter med svær immuninsufficiens kan der ved påbegyndelse af antiretroviral kombinationsbehandling (CART) opstå en inflammatorisk reaktion på asymptomatiske eller residuale opportunistiske infektioner.
English: pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Danish: Hos hivinficerede patienter med svær immuninsufficiens kan der ved påbegyndelse af antiretroviral kombinationsbehandling (CART) opstå en inflammatorisk reaktion på asymptomatiske eller residuale opportunistiske patogener, som kan forårsage alvorlige kliniske tilstande eller forværring af symptomer.
English: Foxes
Danish: Ræve
English: This summary was last updated in May 2008.
Danish: Dette sammendrag blev sidst ajourført i 05-2008.
English: It is recommended to wear rubber gloves when handling the bait.
Danish: Det anbefales at bruge gummihandsker ved håndteringen af lokkemaden.
English: The viruses have been selected because of their ‘low virulence' (limited ability to cause the disease).
Danish: Viraene er valgt på grund af deres lave virulens (begrænsede evne til at fremkalde sygdommen).
English: The marketing authorisation was subsequently renewed in 2005 and varied in April 2008 to include raccoon dogs as a new target species.
Danish: Markedsføringstilladelsen blev fornyet i 2005 og ændret i april 2008 til også at omfatte mårhunde som ny måldyreart.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Rabigen SAG2 to Virbac S.A. on 6 April 2000.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Rabigen SAG2 til Virbac S.A. den 6. april 2000.
English: People handling and distributing this vaccine should be vaccinated against rabies.
Danish: Personer, der håndterer og distribuerer denne vaccine, bør vaccineres mod rabies.
English: The number of baits distributed depends on the number of foxes or raccoon dogs and varies between 13 and 20 per square kilometre.
Danish: Det nødvendige antal lokkemadsenheder afhænger af antallet af ræve eller mårhunde og svinger mellem 13 og 20 pr. kvadratkilometer.
English: People whose immune system is weakened must not be allowed to handle this vaccine.
Danish: Personer med svækket immunforsvar må ikke håndtere denne vaccine.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) RABIGEN SAG2 EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) RABIGEN SAG2 EPAR - sammendrag for offentligheden
English: The distribution of almost four million baits of the product during the field trials over four years have been followed by an intensive surveillance of the vaccination areas.
Danish: Distributionen af næsten fire millioner lokkemadsenheder af præparatet i løbet af feltundersøgelserne, der varede fire år, er blevet efterfulgt af nøje overvågning af vaccinationsområderne.
English: The baits are distributed by land or by air.
Danish: Lokkemaden distribueres direkte på jorden eller fra luften.
English: As raccoon dogs are considered a minor species, no field trials were carried out.
Danish: Da mårhunde betragtes som en mindre art, blev der ikke gennemført feltundersøgelser for disse.
English: No case of vaccine induced rabies was reported, confirming the safety of the vaccine in the field.
Danish: Der blev ikke indberettet tilfælde af vaccineinduceret rabies, hvilket bekræfter sikkerheden ved vaccinen i felten.
English: The vaccine confers 6-month protection against rabies.
Danish: Vaccinen beskytter mod rabies i 6 måneder.
English: In the event of human exposure to the active substance of the vaccine, seek medical advice immediately and show the package leaflet or the label to the doctor.
Danish: Hvis en person udsættes for det aktive stof i vaccinen, skal der straks søges lægehjælp, og indlægssedlen eller etiketten skal vises til lægen.
English: If the foxes or racoon dogs are then exposed to the rabies virus later in life, they do not become infected.
Danish: Hvis rævene eller mårhundene udsættes for rabies senere i deres liv, inficeres de ikke.
English: Rabigen SAG2 can only be used by authorised personnel within the framework of vaccination campaigns against rabies.
Danish: Rabigen SAG2 må kun anvendes af autoriseret personale inden for rammerne af rabiesvaccinationskampagner.
English: The viruses are contained in a sachet within a bait matrix.
Danish: Viraene er indeholdt i et brev i en lokkemadsmatrix.
English: Other information about Rabigen SAG2:
Danish: Andre oplysninger om Rabigen SAG2:
English: Rabigen SAG2 is used for the active immunisation of red foxes (Vulpes vulpes) and raccoon dogs (Nyctereutes procyonoides) to prevent infection by rabies virus.
Danish: Rabigen SAG2 anvendes til aktiv immunisering af rødræve (Vulpes vulpes) og mårhunde (Nyctereutes procyonoides) for at forebygge infektion med rabiesvirus.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Rabigen SAG2 exceed the risks for its use in red foxes and raccoon dogs to prevent infection by rabies virus and recommended that Rabigen SAG2 be given a marketing authorisation.
Danish: Udvalget for Veterinærmedicinske Lægemidler (CVMP) konkluderede, at fordelene ved Rabigen SAG2 opvejer risiciene ved forebyggelse af rabiesinfektion hos rødræve og mårhunde og anbefalede udstedelse af markedsføringstilladelse for Rabigen SAG2.
English: Efficacy was based on the efficacy results from laboratory studies and the extensive use of the vaccine in the field for foxes.
Danish: Virkningen blev bedømt ud fra resultater for ræve fra laboratorieundersøgelser og omfattende anvendelse af vaccinen i felten.
English: As the foxes or raccoon dogs eat the bait, they get exposed to the viruses and make antibodies against them.
Danish: Når rævene eller mårhundene æder lokkemaden, udsættes de for viraene og danner antistoffer mod dem.
English: Raccoon dogs
Danish: Mårhunde
English: Moreover, the use of this vaccine has been efficiently preventing the vaccinated area from re-infection from still contaminated neighbouring areas.
Danish: Desuden har anvendelsen af vaccinen effektivt forhindret, at dyrene i de vaccinerede områder blev smittet på ny med rabies fra nærtliggende områder, hvor der stadig var rabiesforekomster.
English: Rabigen SAG2 is a vaccine.
Danish: Rabigen SAG2 er en vaccine.
English: As a result, rabies decreased significantly in the vaccinated areas until its complete elimination.
Danish: Forekomsten af rabies i de vaccinerede områder faldt derfor betydeligt, og rabies var til sidst helt udryddet.
English: Rabigen contains live rabies viruses.
Danish: Rabigen indeholder levende rabiesvira.
English: Why has Rabigen SAG2 been approved?
Danish: Hvorfor blev Rabigen SAG2 godkendt?
English: When distributed in the wild, the SAG2 rabies vaccine bait was readily taken by free ranging foxes and raccoon dogs.
Danish: Da SAG2-rabiesvaccinen blev distribueret i det fri, blev den hurtigt indtaget af fritgående ræve og mårhunde.
English: What is the risk associated with Rabigen SAG2?
Danish: Hvilken risiko er der forbundet med Rabigen SAG2?
English: It is presented as baits.
Danish: Det leveres i form af lokkemad.
English: No undesirable effects have been shown for Rabigen SAG2.
Danish: Der er ikke konstateret bivirkninger ved Rabigen SAG2.
English: What is Rabigen SAG2?
Danish: Hvad er Rabigen SAG2?
English: Rabigen SAG2 is a vaccine againts rabies.
Danish: Rabigen SAG2 er en vaccine mod rabies.
English: How has Rabigen SAG2 been studied?
Danish: Hvordan blev Rabigen SAG2 undersøgt?
English: What is Rabigen SAG2 used for?
Danish: Hvad anvendes Rabigen SAG2 til?
English: What benefit has Rabigen SAG2 shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Rabigen SAG2?
English: How does Rabigen SAG2 work?
Danish: Hvordan virker Rabigen SAG2?
English: Following bait uptake, adult and fox cubs and raccoon dogs showed significant antibody response.
Danish: Efter optagelsen af lokkemaden i kroppen blev der opnået en væsentlig antistofrespons hos både de voksne og unge ræve og mårhunde.
English: These complications have not been associated with the product itself.
Danish: Disse komplikationer er ikke blevet forbundet med selve produktet.
English: Do not use after this date.
Danish: Må ikke anvendes efter denne dato.
English: Date of first authorisation: 18 February 2016
Danish: Dato for første markedsføringstilladelse: 18. februar 2016
English: Consistent results were determined for both products.
Danish: Der blev bestemt konsistente resultater for begge præparater.
English: Frequency of doses (hours)/ Duration of therapy (days)
Danish: Hyppighed af doser (timer)/ behandlingsvarighed (dage)
English: Administer your next dose immediately and continue at regular intervals as advised by your doctor.
Danish: Administrer din næste dosis med det samme, og fortsæt med regelmæssigt interval, som anvist af din læge.
English: In case of shock, standard medical treatment for shock should be implemented.
Danish: I tilfælde af shock skal medicinsk standardbehandling af shock udføres.
English: ABR annualised bleed rate
Danish: ABR annualiseret blødningsrate
English: • whether you have inhibitors and how high their level is
Danish: • om du har antistoffer og hvor høje niveauerne er
English: If not used immediately, in use storage times and conditions prior to use are the responsibility of the user.
Danish: Hvis det ikke anvendes straks, er opbevaringstiderne under anvendelse og betingelserne før anvendelse brugerens ansvar.
English: It is recommended that every time you use Kovaltry, you note down the name and batch number of the product.
Danish: Det anbefales, at hver gang du bruger Kovaltry registrerer produktets navn og batchnummer.
English: To treat a bleed, your doctor will calculate and adjust your dose and how often it should be given, depending on factors such as:
Danish: Til behandling af en blødning vil din læge beregne og tilpasse din dosis, og hvor hyppigt den skal gives, afhængigt af faktorer, såsom:
English: Be sure that the powder is completely dissolved.
Danish: Sørg for, at pulveret er fuldstændigt opløst.
English: Please contact your doctor if these components cannot be used.
Danish: Kontakt lægen, hvis disse dele ikke kan anvendes.
English: Rarely, inhibitors may develop after the first 50 exposure days but continues throughout life although the risk is uncommon.
Danish: Inhibitorer udvikles sjældent efter de første 50 eksponeringsdage, men fortsætter hele livet, selvom denne risiko ikke er almindelig.
English: Minor surgery including tooth extraction
Danish: Mindre kirurgi herunder tandudtrækning
English: Hold an unopened vial and also a syringe in your hands to warm it to a comfortable temperature (do not exceed 37 °C).
Danish: Hold både et uåbnet hætteglas og sprøjten i dine hænder for at varme det til en behagelig temperatur (ikke over 37 °C).
English: BW: Body weight *Success rate defined as % of bleeds treated successfully with ≤ 2 infusions
Danish: BW: Legemsvægt *Succesrate defineret som % af blødninger behandlet med ≤ 2 infusioner med succes
English: It is unknown whether Kovaltry is excreted in human milk.
Danish: Det er ukendt, om Kovaltry udskilles i human mælk.
English: a heart disease or are at risk of heart disease.
Danish: • en hjertesygdom eller du har risiko for at få en hjertesygdom.
English: Frequencies have been evaluated according to the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100).
Danish: Hyppighederne er blevet evalueret i henhold til den følgende konvention: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100).
English: 4.7 Effects on ability to drive or use machines
Danish: 4.7 Virkning på evnen til at føre motorkøretøj og betjene maskiner
English: The speed of injection should be based on your comfort, but should not be faster than 2 mL per minute.
Danish: Indsprøjtningshastigheden bør afstemmes efter dit velbefindende, men må ikke være hurtigere end 2 ml pr. minut.
English: FVIII inhibition very common (PUPs)* uncommon (PTPs)*
Danish: Meget almindelig (PUPs)* Ikke almindelig (PTPs)*
English: Kovaltry does not contain von Willebrand factor.
Danish: Kovaltry indeholder ikke von Willebrand-faktor.
English: * Based on population PK estimates **AUC calculated for a dose of 50 IU/kg
Danish: * Baseret på populationsfarmakokinetiske estimater ** AUC beregnet for en dosis på 50 IE/kg
English: Hold a pad firmly over the injection site on your outstretched arm for about 2 minutes.
Danish: Hold et kompres fast imod indstiksstedet på din udstrakte arm i ca. 2 minutter.
English: No cases of overdose have been reported.
Danish: Der er ikke indberettet symptomer på overdosering.
English: Kovaltry should be injected intravenously over 2 to 5 minutes depending on the total volume.
Danish: Kovaltry bør injiceres intravenøst over 2-5 minutter afhængigt af det totale volumen.
English: Kovaltry can be used for all age groups.
Danish: Kovaltry kan anvendes til alle aldersgrupper.
English: The powder is dry and white to slightly yellow .
Danish: Pulveret er tørt og hvidt til svagt gult.
English: No animal fertility studies have been conducted with Kovaltry and its effect on human fertility has not been established in controlled clinical trials.
Danish: Der er ikke udført fertilitetsstudier hos dyr med Kovaltry, og virkningen på human fertilitet er ikke klarlagt i kontrollerede kliniske studier.
English: Follow the instructions for use given by your doctor and provided at the end of this leaflet.
Danish: Følg brugsanvisningen, som lægen har givet dig, og som kan ses i slutningen af denne indlægsseddel.
English: Since Kovaltry is a replacement protein of endogenous factor VIII, no adverse effects on fertility are expected.
Danish: Da Kovaltry er et erstatningsprotein for endogent faktor VIII, forventes der ingen bivirkninger med hensyn til fertiliteten.
English: The new expiry date must be noted on the outer carton when the medicine is removed from the refrigerator.
Danish: Den nye udløbsdato skal noteres på den ydre karton, når lægemidlet tages ud af køleskabet.
English: Of note, annualised bleeding rate (ABR) is not comparable between different factor concentrates and between different clinical studies.
Danish: Det bør bemærkes, at årlig blødningsrate (ABR) ikke kan sammenlignes mellem forskellige faktorkoncentrater og forskellige kliniske studier.
English: Laboratory tests at suitable intervals help to ensure you always have adequate factor VIII levels.
Danish: Laboratorieprøver med passende mellemrum hjælper med at sikre, at du altid har tilstrækkelige koncentrationer af faktor VIII.
English: The solvent is a clear liquid.
Danish: Solvensen er en klar væske.
English: In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of coagulation analysis (plasma factor VIII activity) is indispensable.
Danish: Især i tilfælde af større kirurgiske indgreb er præcis overvågning af substitutionsbehandlingen ved hjælp af koagulationsanalyse (plasmafaktor VIII-aktivitet) helt nødvendig.
English: Kovaltry can be used in children of all ages.
Danish: Kovaltry kan anvendes til børn i alle aldre.
English: Non-clinical data reveal no special risk for humans based on safety pharmacology, in vitro genotoxicity, and short term repeat-dose toxicity studies.
Danish: Non-kliniske data viser ingen speciel risiko for mennesker vurderet ud fra sikkerhedsfarmakologi, in vitro genotoksicitet og kortvarige studier af toksicitet efter gentagne doser.
English: Kovaltry is not likely to affect the fertility in male or female patients, as the active substance is naturally occurring in the body.
Danish: Det er ikke sandsynligt, at Kovaltry påvirker frugtbarheden hos mænd eller kvinder, da det aktive stof forekommer naturligt i kroppen.
English: Kovaltry is prepared without the addition of any human or animal derived protein in the cell culture process, purification or final formulation.
Danish: Kovaltry fremstilles uden tilsætning af noget protein af human eller animalsk oprindelse i cellekulturproceduren, oprensningen eller den endelige formulering.