FrancophonIA/ELRC3.0 huggingface dataset:
English: This result was similar to that in patients taking another form of tenofovir (tenofovir disoproxil fumarate) where 93% had very low viral DNA levels.
Danish: Dette stemte overens med det resultat, der sås hos patienter, der fik en anden form af tenofovir (tenofovirdisoproxilfumarat), hvor 93 % havde meget lave niveauer af antiviralt dna.
English: Vemlidy reduces levels of hepatitis B virus in most patients.
Danish: Vemlidy reducerer niveauet af hepatitis B-virus hos de fleste patienter.
English: It contains the active substance tenofovir alafenamide.
Danish: Det indeholder det aktive stof tenofoviralafenamid.
English: For more information about treatment with Vemlidy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Vemlidy, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: It is converted in the body into its active compound tenofovir, which blocks the activity of reverse transcriptase, an enzyme made by the hepatitis B virus that allows it to reproduce itself in the cells it has infected.
Danish: Det omdannes i kroppen til dets aktive bestanddel, tenofovir, som blokerer aktiviteten af revers transcriptase, et enzym, som hepatitis B-virussen producerer, så det kan formere sig i de celler, det har inficeret.
English: It is not intended to provide practical advice on how to use Vemlidy.
Danish: Det er ikke en praktisk vejledning i, hvordan Vemlidy bør anvendes.
English: Why is Vemlidy approved?
Danish: Hvorfor blev Vemlidy godkendt?
English: What is Vemlidy and what is it used for?
Danish: Hvad er Vemlidy, og hvad anvendes det til?
English: In a study of 426 patients with ‘e-antigen negative' chronic hepatitis, 94% of patients on Vemlidy had very low levels of viral DNA after 48 weeks of treatment.
Danish: I en undersøgelse af 426 patienter med "e-antigen-negativ" kronisk hepatitis havde 94 % af de patienter, der blev behandlet med Vemlidy, meget lave niveauer af viralt dna efter 48 ugers behandling.
English: With regard to its risks, the side effects of Vemlidy are manageable.
Danish: For så vidt angår risiciene ved lægemidlet, er bivirkningerne ved Vemlidy håndterbare.
English: What are the risks associated with Vemlidy?
Danish: Hvilke risici er der forbundet med Vemlidy?
English: Vemlidy is an antiviral medicine for treating chronic (long-term) hepatitis B, an infectious disease that affects the liver.
Danish: Vemlidy er et antiviralt lægemiddel til behandling af kronisk (langvarig) hepatitis B, der er en smitsom leversygdom.
English: In a second study of 875 patients with ‘e-antigen positive' chronic hepatitis, 64% of patients taking Vemlidy and 67% of those taking tenofovir disoproxil fumarate had very low levels of viral DNA after 48 weeks.
Danish: I en anden undersøgelse af 875 patienter med "e-antigen-positiv" kronisk hepatitis havde 64 % af de patienter, der fik Vemlidy, og 67 % af dem, der fik tenofovirdisoproxilfumarat, meget lave niveauer af viralt dna efter 48 uger.
English: For practical information about using Vemlidy, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Vemlidy, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Vemlidy suppresses levels of hepatitis B virus in the body, and its effectiveness is comparable to that of another tenofovir medicine (tenofovir disoproxil fumarate).
Danish: Vemlidy sænker niveauet af hepatitis B-virus i kroppen, og dets virkning er sammenlignelig med et andet tenofovir-holdigt lægemiddel (tenofovirdisoproxilfumarat).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Vemlidy have been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Vemlidy.
English: The active substance in Vemlidy, tenofovir alafenamide, works by stopping the hepatitis B virus in the liver from multiplying.
Danish: Det aktive stof i Vemlidy, tenofoviralafenamid, virker ved at forhindre hepatitis B-virusset i leveren i at formere sig.
English: How does Vemlidy work?
Danish: Hvordan virker Vemlidy?
English: How is Vemlidy used?
Danish: Hvordan anvendes Vemlidy?
English: What benefits of Vemlidy have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Vemlidy?
English: These reactions usually regress within one week.
Danish: Disse forandringer forsvinder sædvanligvis inden for en uge.
English: Hypersensitivity reactions may occur.
Danish: Hypersensitivitetsreaktioner kan forekomme.
English: These are rare and appropriate symptomatic treatment should be administered.
Danish: Disse reaktioner er sjældne og passende symptomatisk behandling bør iværksættes.
English: Date of first authorisation: 26.03.2001 Date of last renewal: 18.04.2006
Danish: Dato for første markedsføringstilladelse: 26.03.2001 Dato for seneste fornyelse af markedsføringstilladelse: 18.04.2006
English: The reconstituted content shall be a milky emulsion.
Danish: Det rekonstituerede indhold skal være en mælkeagtig emulsion.
English: Accidental injection is dangerous
Danish: Utilsigtet injektion er farlig.
English: Casein hydrolysate Collagen hydrolysate Salts
Danish: Casein hydrolysat Kollagen hydrolysat Salte
English: Overdose:
Danish: Overdosis:
English: Store in a refrigerator (2 °C - 8 °C).
Danish: Opbevares i køleskab (2°C - 8°C ).
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Nærmere oplysninger om dette veterinærlægemiddel er tilgængelige på webstedet for Det Europæiske Lægemiddelagentur http://www.ema.europa.eu/
English: No undesirable effects other than those mentioned in the “Adverse reactions” section have been observed after the administration of several doses.
Danish: Ingen andre bivirkninger end de, der er nævnt i afsnittet Bivirkninger, er observeret efter administration af adskillige doser.
English: Solvent : homogeneous white emulsion
Danish: Solvens: homogen hvid emulsion.
English: Shelf life of the veterinary medicinal product as packaged for sale: 24 months.
Danish: Opbevaringstid for veterinærlægemidlet i salgspakning: 24 måneder.
English: Second injection: 1 to 2 weeks before the expected date of whelping.
Danish: Anden injektion: 1 til 2 uger før forventet fødsel.
English: Revaccination: during each pregnancy, according to the same schedule.
Danish: Revaccination: under hver drægtighed, i henhold til samme vaccinationsskema.
English: Pharmacotherapeutic group : Inactivated viral vaccines ATCvet code: QI07AA06
Danish: Farmakoterapeutisk gruppe: Inaktiverede virale vacciner ATCvet-kode: QI07AA06
English: Special precautions for use in animals: Vaccinate only healthy animals.
Danish: Special forholdsregler til brug hos dyr: Vacciner kun raske dyr.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Bottle
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Flaske
English: Laboratory of Lyon Gerland 254, Avenue Marcel Mérieux 69007 Lyon
Danish: Laboratoire Lyon Gerland 254, Avenue Marcel Mérieux 69007 Lyon
English: Dogs (pregnant bitches)
Danish: Hund (drægtige tæver)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance :
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Aktivt stof
English: EU/2/01/029/001 10 doses: powder (10 bottles) + solvent (10 bottles) EU/2/01/029/002 50 doses: powder (50 bottles) + solvent (50 bottles) EU/2/01/029/003 1 dose: powder (1 bottle) + solvent (1 bottle)
Danish: EU/2/01/029/001 10 doser: pulver (10 flasker) + solvens (10 flasker) EU/2/01/029/002 50 doser: pulver (50 flasker) + solvens (50 flasker) EU/2/01/029/003 1 dosis: pulver (1 flaske) + solvens (1 flaske)
English: Polyoxyethylene fatty acids Ether of fatty alcohols and of polyols Triethanolamine
Danish: Polyoxyethylen fede syrer Æter af fede alkoholer og polyoler Triethanolamin
English: B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
Danish: B. BETINGELSER ELLER BEGRÆNSNINGER FOR MARKEDSFØRINGSTILLADELSEN VEDRØRENDE UDLEVERING OG BRUG
English: The vaccine may commonly cause transient oedema at the site of injection.
Danish: Vaccinen kan almindeligvis forårsage forbigående hævelse på injektionsstedet.
English: 1 dose: powder (1 bottle) + solvent (1 bottle)
Danish: 1 dosis: pulver (1 flaske) + solvens (1 flaske)
English: EXP {month/year} Once reconstituted use immediately.
Danish: EXP {måneder/år} Anvendes straks efter rekonstituering.
English: Purified subunit vaccine for the active immunisation of pregnant bitches to induce passive immunity in puppies against herpesvirus-induced fatal neonatal disease.
Danish: Renset subunit vaccine til aktiv immunisering af drægtige tæver for at inducere passiv immunitet af hvalpe mod herpesvirus induceret fatal neonatal sygdom.
English: In order for immunity to be conferred to the puppies, sufficient intake of colostrum is required.
Danish: For at immunitet overføres til hvalpene er det vigtigt at sikre tilstrækkeligt colostrumindtag.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: Do not mix with any other veterinary medicinal product except the solvent supplied for use with the veterinary medicinal product.
Danish: Må ikke blandes med lægemidler til dyr undtaget solvensen, der leveres til brug med dette veterinærlægemiddel.
English: Following reconstitution of the powder with the solvent, inject one dose (1ml) of the vaccine via the subcutaneous route, according to the following schedule:
Danish: Opløs pulveret i solvensen og injicer subkutant en dosis (1ml) af vaccinen i henhold til følgende skema:
English: Name and address of the manufacturer of the biological active substance(s)
Danish: Navn og adresse på fremstillerne af det biologisk aktive stof
English: 10 doses: powder (10 bottles) + solvent (10 bottles) 50 doses: powder (50 bottles) + solvent (50 bottles)
Danish: 10 doser: pulver (10 flasker) + solvens (10 flasker) 50 doser: pulver (50 flasker) + solvens (50 flasker)
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Danish: Hyppigheden af bivirkninger er defineret som: - Meget almindelige (mere end 1 ud af 10 dyr, der viser bivirkninger i løbet af en behandling) - Almindelige (mere end 1, men færre end 10 dyr ud af 100 dyr) - Ualmindelige (mere end 1, men færre end 10 dyr ud af 1.000 dyr) - Sjældne (mere end 1, men færre end 10 dyr ud af 10.000 dyr) - Meget sjældne (færre end 1 dyr ud af 10.000 dyr, herunder isolerede rapporter).
English: Pregnancy: This vaccine is specifically indicated during pregnancy.
Danish: Drægtighed: Denne vaccine er især indiceret til anvendelse under drægtighed.
English: Type I glass bottle containing powder for 1-dose and glass bottle containing 1-ml of solvent.
Danish: Type I flaske indeholdende pulver à 1 dosis og hætteglas à 1ml solvens.
English: Light paraffin oil
Danish: Paraffin olie, tynd
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with the local requirements.
Danish: Ikke anvendte veterinærlægemidler, samt affald heraf bør destrueres i henhold til lokale retningslinier.
English: This vaccine is specifically indicated during pregnancy.
Danish: Denne vaccine er især indiceret til anvendelse under drægtighed.
English: Shelf life after reconstitution: use immediately
Danish: Opbevaringstid efter rekonstituering: Anvendes straks.
English: Eurican Herpes 205 solvent
Danish: Eurican Herpes 205 solvens.
English: Special precautions to be taken by the person administrating the veterinary medicinal product to animals:
Danish: Særlige forholdsregler der skal træffes af personer, der administrerer lægemidlet til dyr: Til brugeren:
English: Per 1-ml dose: Canine herpesvirus (F205 strain) antigens ............................................... 0.3 to 1.75 µg* *expressed in µg of gB glycoproteins
Danish: Herpesvirus (F 205 stamme) antigener til hund .......................................................... 0,3 - 1,75 µg* *udtrykt i µg af gB glykoproteiner
English: Box of 2 x 1 bottle, 2 x 10 bottles and 2 x 50 bottles.
Danish: Æske med 2 x 1 flaske, 2 x 10 flasker og 2 x 50 flasker.
English: Active immunisation of bitches to prevent mortality, clinical signs and lesions in puppies resulting from canine herpes virus infections acquired in the first few days of life through passive immunity.
Danish: Aktiv immunisering af tæver for at inducere passiv immunitet hos hvalpe og dermed forebygge dødsfald, kliniske symptomer og læsioner forårsaget af infektioner med hundens herpesvirus inden for de første levedage.
English: First injection: Either during heat or 7 -10 days after the presumed date of mating.
Danish: Første injektion: I perioden fra start af løbetid til senest 10 dage efter formodet parringsdato.
English: Aseptically reconstitute the contents of the powder with the solvent supplied with this vaccine.
Danish: Anvend aseptisk procedure ved rekonstituering af pulveret med den medfølgende solvens.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Box of 2 x 1 bottle, 2 x 10 bottles and 2 x 50 bottles
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æske med 2 x 1 flaske, 2 x 10 flasker og 2 x 50 flasker
English: Powder and solvent for emulsion for injection.
Danish: Pulver og solvens til injektionsvæske, emulsion.
English: Abortion and premature parturition can occur as a result of CHV infection in bitches, the protection of the bitch against infection has not been studied for this vaccine.
Danish: Beskyttelsen af tæven imod infektion er ikke blevet undersøgt for denne vaccine.
English: Subcutaneous use.
Danish: Subkutant.
English: Manufacturer responsible for batch release: MERIAL, Laboratoire Porte des Alpes, Rue de l'Aviation, 69800 Saint Priest, France
Danish: Laboratoire Porte des Alpes, Rue de l'Aviation 69800 Saint Priest
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Active substance:
Danish: ANGIVELSE AF DET AKTIVE STOF OG ANDRE INDHOLDSSTOFFER Aktivt stof
English: Once reconstituted use immediately.
Danish: Bør anvendes umiddelbart efter opløsning.
English: Eurican Herpes 205 powder for injection
Danish: Eurican Herpes 205 pulver til injektionsvæske.
English: Eurican Herpes 205 powder and solvent for emulsion for injection.
Danish: Eurican Herpes 205 pulver og solvens til injektionsvæske, emulsion.
English: Light paraffin oil ......................................................................................................... 224.8 to 244.1 mg For the full list of excipients, see section 6.1.
Danish: Paraffinolie, tynd ........................................................................................................ 224,8 - 244,1 mg Alle hjælpestoffer er anført under pkt.
English: PACKAGE LEAFLET FOR: Eurican Herpes 205 powder and solvent for emulsion for injection
Danish: INDLÆGSSEDDEL TIL Eurican Herpes 205 pulver og solvens til injektionsvæske, emulsion.
English: Adjuvant:
Danish: Adjuvans
English: Light paraffin oil ......................................................................................................... 224.8 to 244.1 mg Lyophilisate : white pellet.
Danish: Paraffinolie, tynd ........................................................................................................ 224,8 - 244,1 mg Pulver: hvid pille.
English: The bottles are closed with a butyl elastomer closure and sealed with an aluminium cap Box of 2 x 1 bottle, 2 x 10 bottles and 2 x 50 bottles.
Danish: Flaskerne lukkes med butyl elastomer prop og forsegles med en aluminiumshætte.
English: Incompatibilities:
Danish: Salgspakninger:
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY OR USE C. STATEMENT OF THE MRLs
Danish: Fremstiller ansvarlig for batchfrigivelse: Merial
English: Powder and solvent for emulsion for injection Lyophilisate : white pellet.
Danish: Pulver: hvid pille.
English: Strength Pharmaceutical form
Danish: EU-nummer Særnavn Styrke Lægemiddel¬f orm
English: The European Commission granted a marketing authorisation valid throughout the European Union for Enviage to Novartis Europharm Limited on 22 August 2007.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Enviage til Novartis Europharm Limited den 22. august 2007.
English: It should be taken with a light meal preferably at the same time each day, but grapefruit juice should not be taken together with Enviage.
Danish: Den skal tages sammen med et let måltid, helst på samme tid hver dag, men der må ikke indtages grapefrugtjuice sammen med Enviage.
English: The blood pressure was measured in ‘millimetres of mercury' (mmHg).
Danish: Blodtrykket blev målt i ‘millimeter kviksølv' (mmHg).
English: The effects of Enviage were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Enviage blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: It is available as tablets (pink and round: 150 mg; red and oval: 300 mg).
Danish: Det leveres som tabletter (lyserøde og runde: 150 mg, røde og ovale 300 mg: 300 mg).
English: Enviage is not recommended for use in patients below 18 years of age, because of a lack of information on safety and effectiveness in this age group.
Danish: Enviage anbefales ikke til patienter under 18 år på grund af manglende data om sikkerhed og effekt i denne
English: The most common side effect with Enviage (seen in between 1 and 10 patients in 100) is diarrhoea.
Danish: Den almindeligste bivirkning ved Enviage (som ses hos mellem 1 og 10 patienter ud af 100) er diarré.
English: The dose of Enviage may be increased to 300 mg once a day in patients whose blood pressure is not adequately controlled.
Danish: Dosis af Enviage kan øges til 300 mg én gang dagligt hos patienter, hvis blodtryk ikke er tilstrækkeligt reguleret.
English: In five of the studies, the effects of Enviage taken alone were compared with those of placebo (a dummy treatment).
Danish: I fem af undersøgelserne blev virkningerne af Enviage anvendt alene sammenlignet med virkningerne af placebo (virkningsløs behandling).
English: It must not be used in patients who have had angioedema (swelling under the skin) with aliskiren or in women who are more than three months pregnant.
Danish: Det må ikke anvendes hos patienter, som har haft angioødem (hævelse under huden) med aliskiren, eller hos kvinder, som er mere end tre måneder henne i graviditeten.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Enviage are greater than its risks for the treatment of essential hypertension.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) fandt, at fordelene ved Enviage opvejer risiciene ved behandling af essentiel hypertension.
English: Enviage was studied in 14 main studies involving over 10,000 patients with essential hypertension.
Danish: Enviage blev anvendt i 14 hovedundersøgelser, hvori der deltog 10 000 patienter med essentiel hypertension.
English: Enviage is a medicine that contains the active substance aliskiren.
Danish: Enviage er et lægemiddel, der indeholder det aktive stof aliskiren.
English: Enviage is used to treat essential hypertension (high blood pressure).
Danish: Enviage anvendes til behandling af essentiel hypertension (for højt blodtryk).
English: By blocking the production of angiotensin I, levels of both angiotensin I and angiotensin II fall.
Danish: Når produktionen af angiotensin I blokeres, mindskes indholdet af både angiotensin I og angiotensin II.
English: Enviage also reduced blood pressure in patients with diabetes and patients who were overweight.
Danish: Enviage nedsatte også blodtrykket hos patienter med sukkersyge og hos overvægtige patienter.
English: Enviage must also not be taken with ciclosporin (a medicine that reduces the activity of the immune system), quinidine (used to correct irregular heartbeat) or verapamil (used to treat heart problems).
Danish: Enviage må ikke tages sammen med ciclosporin (et lægemiddel, som nedsætter aktiviteten i immunsystemet), quinidin (anvendes til afhjælpning af uregelmæssig hjerterytme) eller verapamil (anvendes til behandling af hjerteproblemer).
English: The active substance in Enviage, aliskiren, is a renin inhibitor.
Danish: Det aktive stof i Enviage, aliskiren, er en reninhæmmer.
English: Enviage on its own was more effective than placebo and as effective as comparator treatments in reducing blood pressure.
Danish: Når Enviage blev anvendt alene, var det mere effektivt end placebo og lige så effektivt som sammenligningslægemidlerne til at nedsætte blodtrykket.
English: The studies lasted between six and 52 weeks and the main measure of effectiveness was the change in blood pressure during either the resting phase of the heartbeat (‘diastolic') or when the chambers of the heart were contracting (‘systolic').
Danish: Undersøgelserne varede mellem seks og 52 uger, og det primære effektmål var ændringen i blodtrykket, som enten var det diastoliske blodtryk (blodtrykket i hvilefasen mellem to hjerteslag) eller det systoliske blodtryk (blodtrykket i hjertekamrenes sammentrækningsfase).
English: The studies also showed that Enviage, when taken in combination with other medicines (especially hydrochlorothiazide), can produce additional decreases in blood pressure compared with the decreases produced by these medicines when they are taken without Enviage.
Danish: Undersøgelserne viste også, at når Enviage anvendes sammen med andre lægemidler (især hydrochlorthiazid), kan det mindske blodtrykket mere, end når disse lægemidler anvendes uden
English: The recommended dose of Enviage is 150 mg once a day, either taken alone or in combination with other medicines for hypertension.
Danish: Den anbefalede dosis af Enviage er 150 mg én gang dagligt, anvendt enten alene eller sammen med anden medicin mod for højt blodtryk.
English: For the full list of all side effects reported with Enviage, see the Package Leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Enviage fremgår af indlægssedlen.
English: Combination studies looked at Enviage used with an angiotensin converting enzyme inhibitor (ramipril), an angiotensin receptor blocker (valsartan), a beta-blocker (atenolol), a calcium-channel blocker (amlodipine) and a diuretic (hydrochlorothiazide).
Danish: I kombinationsundersøgelserne blev Enviage anvendt sammen med en angiotensinkonvertaseenzymhæmmer, ramipril, en angiotensinreceptorblokker (valsartan), en betablokker (atenolol), en kalciumkanalblokker (amlodipin) og et vanddrivende middel (hydrochlorthiazid).
English: Enviage should not be used by people who may be hypersensitive (allergic) to aliskiren or any of the other ingredients.
Danish: Enviage bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for aliskiren eller andre af indholdsstofferne.