FrancophonIA/ELRC3.0 huggingface dataset:
English: No milk residue data are available following subcutaneous administration of closantel to dairy animals in the dry period.
Danish: Der foreligger ingen restkoncentrationsdata for mælkeproducerende dyr efter subkutan indgift af closantel i goldperioden.
English: Fasifree 10% Triclabendazole 100 mg/ml
Danish: Fasifree 10 % Triclabendazol
English: Do not use within 1 year prior to the first lambing in ewes intended to produce milk for human consumption.
Danish: Må ikke anvendes inden for et år før første læmning hos får, der er bestemt til mælkeproduktion til menneskeligt konsum.
English: It is therefore considered that the only acceptable use of clorsulon in cattle intended for production of milk for human consumption would involve administration to young animals before the first pregnancy and at least 1 year before the first calving.
Danish: Udvalget finder derfor, at den eneste acceptable anvendelse af clorsulon til kvæg, der producerer mælk til menneskeligt konsum, at anvendelse til unge dyr, der ikke her været med kalv og mindst et år før første kælvning.
English: Defining a safe concentration for closantel in milk - sheep
Danish: Fastlæggelse af en sikker koncentration af closantel mælk - får
English: Assuming consumption of 1.5 litre of milk per day and a marker to total residues ratio of 0.5, it is concluded that the concentration of nitroxinil in milk that can be considered safe is 20 µg/l.
Danish: Under forudsætning af en daglig indtagelse af mælk på 1,5 l og et forhold mellem restmarkør og totale restkoncentrationer på 0,5 kan den risikofri koncentration af nitroxinil i mælk beregnes til 20 µg/l.
English: It is therefore considered that the only acceptable subcutaneous use of rafoxanide in cattle intended for production of milk for human consumption would involve administration to young animals before the first pregnancy and at least 1 year before the first calving.
Danish: Udvalget finder derfor, at den eneste acceptable anvendelse af rafoxanid til kvæg, der producerer mælk til menneskeligt konsum, er anvendelse til unge dyr inden disses første drægtighedsperiode og mindst et år før første kælvning.
English: Not authorised for use in cattle producing milk for human consumption including during the dry period.
Danish: Ikke godkendt til anvendelse hos kvæg, der producerer mælk til menneskeligt konsum, herunder i goldperioden.
English: K. For products listed in Annex I containing triclabendazole as sole active and administered orally to sheep:
Danish: K. For de i bilag I opførte lægemidler, der indeholder triclabendazol som eneste aktive stof og administreres oralt til får:
English: Virbamec super Clorsulon Ivermectin subcutaneous Cattle
Danish: Virbamec super Clorsulon Ivermectin
English: Fascinex 100 Triclabendazole 100 mg/ml
Danish: Fascinex 100 Triclabendazol
English: Fasinex 5% Triclabendazole 5 g/100ml
Danish: Fasinex 5 % Triclabendazol
English: Sheep, Lambs
Danish: Får, lam
English: Endofluke 10 Triclabendazole 100 mg/ml
Danish: Endofluke 10 Triclabendazol
English: Residues of closantel in milk following pour-on administration - cattle
Danish: Restkoncentrationer af closantel i mælk efter administration af pour-on - kvæg
English: L. For products listed in Annex I containing triclabendazole as sole active and administered as orally to goats:
Danish: L. For de i bilag I opførte lægemidler, der indeholder triclabendazol som eneste aktive stof og administreres oralt til geder:
English: MRLs established in muscle, fat, liver and kidney lead to a theoretical maximum daily intake of residues equivalent to 80% of the ADI.
Danish: På grundlag af maksimalgrænseværdierne for restkoncentrationer i muskel, lever og nyre kan den teoretiske maksimale daglige indtagelse af restkoncentrationer beregnes til at udgøre 80 % af ADIværdien.
English: Do not use within 1 year prior to the first calving in heifers intended to produce milk for human consumption.
Danish: Må ikke anvendes inden for et år før første læmning hos geder, der er bestemt til mælkeproduktion til menneskeligt konsum.
English: Fascinex 5% Triclabendazole 50 mg/ml
Danish: Fascinex 5 % Triclabendazol
English: Assuming consumption of 1.5 litre of milk per day and a marker to total residues ratio of 0.7, it is concluded that the concentration of closantel in milk that can be considered safe is 45 µg/l.
Danish: Under forudsætning af en daglig indtagelse af mælk på 1,5 l og et forhold mellem restmarkør og totale restkoncentrationer på 0,7 kan den risikofri koncentration af closantel i mælk beregnes til 45 µg/l.
English: Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer THE NETHERLANDS
Danish: 5831 AN Boxmeer
English: Tolomec Plus Clorsulon Ivermectin subcutaneous Cattle
Danish: Tolomec Plus Clorsulon Ivermectin
English: Defining a safe concentration for triclabendazole in milk - cattle
Danish: Bestemmelse af en risikofri koncentration af triclabendazol i mælk - kvæg
English: IVOMEC PLUS Clorsulon Ivermectin subcutaneous Cattle
Danish: IVOMEC PLUS Clorsulon Ivermectin
English: Not authorised for use in ewes producing milk for human consumption including during the dry period.
Danish: Ikke godkendt til anvendelse hos får, der producerer mælk til menneskeligt konsum, herunder i goldperioden.
English: Fascinex 10% Triclabendazole 100 mg/ml
Danish: Fascinex 10 % Triclabendazol
English: Do not use within 1 year prior to the first lambing/kidding in animals intended to produce milk for human consumption.
Danish: Må ikke anvendes inden for et år før første læmning hos dyr, der er bestemt til mælkeproduktion til menneskeligt konsum.
English: Not authorised for use in goats producing milk for human consumption including during the dry period.
Danish: Ikke godkendt til anvendelse hos geder, der producerer mælk til menneskeligt konsum, herunder i goldperioden.
English: No milk residue data are available following pour-on administration to dairy animals of closantel in the dry period.
Danish: Der foreligger ingen restkoncentrationsdata for mælk fra mælkeproducerende dyr efter behandling med closantel som pour-on i goldperioden.
English: Closamectin Closantel lvermectin subcutaneous Cattle
Danish: Closamectin Closantel lvermectin
English: Orafluke 5% Rafoxanide Fenbendazole
Danish: Orafluke 5 % Rafoxanid Fenbendazol
English: Mectaject Plus Clorsulon Ivermectin subcutaneous Cattle
Danish: Mectaject Plus Clorsulon Ivermectin
English: It is concluded that the only acceptable use of triclabendazole in ewes intended for production of milk for human consumption would involve administration to young animals before the first pregnancy and at least 1 year before the first lambing.
Danish: Det konkluderes, at den eneste acceptable anvendelse af triclabendazol til malkefår er anvendelse til unge dyr inden de første gang bliver drægtige og mindst et år før første læmning.
English: Kepromec Super Clorsulon Ivermectin subcutaneous Cattle
Danish: Kepromec Super Clorsulon Ivermectin
English: Fascicur 5% Triclabendazole 50 mg/ml
Danish: Fascicur 5 % Triclabendazol
English: Cevamec D Clorsulon Ivermectin subcutaneous Cattle
Danish: Cevamec D Clorsulon Ivermectin
English: Triclanil 5% Triclabendazole 50 mg/ml
Danish: Triclanil 5 % Triclabendazol
English: Fascicur 10% Triclabendazole 100 mg/ml
Danish: Fascicur 10 % Triclabendazol
English: It is concluded that the only acceptable use of closantel in ewes intended for production of milk for human consumption would involve administration to young animals before the first pregnancy and at least 1 year before the first lambing.
Danish: Det konkluderes, at den eneste acceptable anvendelse af closantel til malkefår er anvendelse til unge dyr inden de første gang bliver drægtige og mindst et år før første læmning.
English: Triclabendazole Cattle pour-on
Danish: Closantel intramuskulær Kvæg
English: 90 mg/ml
Danish: 10 g/100 ml
English: Triclaben 10% Triclabendazole 100 mg/ml
Danish: Triclaben 10 % Triclabendazol
English: After the Commission decision the Member State competent authorities, in liaison with the reference Member State, will update the product information as required.
Danish: Efter Kommissionens afgørelse vil medlemslandenes kompetente myndigheder i samarbejde med referencelandet opdatere produktinformationen som påkrævet.
English: Therefore, this SmPC, labelling and package leaflet may not necessarily represent the current text.
Danish: Produktresume, etikettering og indlægsseddel herunder repræsenterer derfor ikke nødvendigvis den gældende tekst.
English: Summary of product characteristics, labelling and package leaflet
Danish: Produktresume, etikettering og indlægsseddel
English: The valid summary of product characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Danish: Det gældende produktresumé, etikettering og indlægsseddel er den endelige udgave, der fremkom under koordinationsgruppens procedure.
English: Note: This SmPC, labelling and packages leaflet is the version valid at the time of Commission decision.
Danish: Bemærk: Produktresume, etikettering og indlægsseddel herunder er den gældende version på tidspunktet for Kommissionens afgørelse.
English: The Mutual Recognition Procedure (UK/V/0145/001/II/007) started on 30 January 2009.
Danish: Den gensidige anerkendelsesprocedure (UK/V/0145/001/II/007) blev indledt den 30. januar 2009.
English: The application was submitted in the framework of Article 6 of Commission Regulation (EC) No 1084/2003, where the Reference Member State was the United Kingdom and the Concerned Member States were Austria, Belgium, Germany, Greece, Spain, France, Ireland, Italy, Luxembourg, the Netherlands and Portugal.
Danish: Ansøgningen blev indgivet i henhold til artikel 6 i Kommissionens forordning (EF) nr. 1084/2003, hvor referencemedlemsstaten var Det Forenede Kongerige, og de berørte medlemsstater var Østrig, Belgien, Tyskland, Grækenland, Spanien, Frankrig, Irland, Italien, Luxembourg, Nederlandene og Portugal.
English: Article 6(12) of Commission Regulation (EC) No 1084/2003.
Danish: Artikel 6, stk. 12, i Kommissionens forordning (EF) nr. 1084/2003.
English: Opinion following an Article 6(12)
Danish: Udtalelse som følge af en sag indbragt i henhold til artikel 6, stk. 12
English: Porcilis PRRS is an immunological veterinary medicinal product containing the Porcine Reproductive and Respiratory Syndrome (PRRS) virus.
Danish: Porcilis PRRS er et immunologisk lægemiddel til dyr, der indeholder PRRS-virus (porcint reproduktionsog respirationssyndrom).
English: Based on the rapporteurs' assessment of the currently available data, the CVMP adopted, on 19 May 2010, an opinion recommending that the variation application applied for the veterinary medicinal product Porcilis PRRS satisfies the criteria for approval.
Danish: På baggrund af rapportørernes vurdering af de aktuelt tilgængelige data vedtog CVMP den 19. maj 2010 en udtalelse, hvor udvalget anbefalede, at ansøgningen om en ændring for lægemidlet til dyr Porcilis PRRS opfylder godkendelseskriterierne.
English: referral for Porcilis
Danish: 1, om Porcilis PRRS
English: On 2 October 2009 the United Kingdom, referred the matter to the Agency under Article 39 of Directive 2001/82/EC as amended by reference to Article 6(12) of Regulation (EC) No 1084/2003 due to concerns raised by Spain relating to the quality and efficacy of the simultaneous administration of Porcilis PRRS with Porcilis M Hyo.
Danish: Den 2. oktober 2009 indbragte Det Forenede Kongerige sagen for Det Europæiske Lægemiddelagentur i henhold til artikel 39 i direktiv 2001/82/EF, med senere ændringer, under henvisning til artikel 6, stk. 12, i forordning (EF) nr. 1084/2003 som følge af de betænkeligheder, Spanien havde givet udtryk for med hensyn til kvaliteten og virkningen af samtidig indgivelse af Porcilis PRRS og Porcilis M Hyo.
English: The product is indicated for use in breeding and finishing pigs from 2 weeks of age.
Danish: Lægemidlet er indiceret til brug hos avls- og slagtesvin fra 2-ugers-alderen.
English: The marketing authorisation holder Intervet International B.V. submitted an application for a Type II variation subject to Mutual Recognition Procedure for Porcilis PRRS concerning simultaneous administration with Porcilis M Hyo.
Danish: Indehaveren af markedsføringstilladelsen, Intervet International B.V., indsendte i henhold til den gensidige anerkendelsesprocedure en ansøgning om en type II-ændring for Porcilis PRRS, som vedrørte samtidig indgivelse med Porcilis M Hyo.
English: Further information on Steglujan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Steglujan findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It is used together with diet and exercise in the following patients:
Danish: Det anvendes sammen med diæt og motion hos følgende patienter:
English: What measures are being taken to ensure the safe and effective use of Steglujan?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Steglujan?
English: As for all medicines, data on the use of Steglujan is continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Steglujan løbende overvåget.
English: What is Steglujan and what is it used for?
Danish: Hvad er Steglujan, og hvad anvendes det til?
English: Why is Steglujan authorised in the EU?
Danish: Hvorfor blev Steglujan godkendt i EU?
English: For more information about using Steglujan, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Steglujan, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: At the start of the studies, patients' HbA1c was above 7.0%.
Danish: Ved starten af undersøgelserne var patienternes HbA1c-niveau over 7,0 %.
English: An overview of Steglujan and why it is authorised in the EU
Danish: En oversigt over Steglujan og hvorfor det er godkendt i EU
English: What are the risks associated with Steglujan?
Danish: Hvilke risici er der forbundet med Steglujan?
English: Other information about Steglujan
Danish: Andre oplysninger om Steglujan
English: • patients who are already taking ertugliflozin and sitagliptin as separate tablets.
Danish: • patienter, der i forvejen får ertugliflozin og sitagliptin som separate tabletter.
English: The European Medicines Agency decided that Steglujan's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Steglujan opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Steglujan contains the active substances ertugliflozin and sitagliptin.
Danish: Steglujan indeholder de aktive stoffer ertugliflozin og sitagliptin.
English: In patients whose blood sugar needs further control, the dose can be increased to one 15 mg/100 mg tablet once a day.
Danish: Hos patienter, hvis blodsukker behøver yderligere regulering, kan dosen øges til én 15 mg/100 mg-tablet én gang dagligt.
English: The most common side effects with Steglujan (which may affect more than 1 in 10 people) are fungal infections of the vagina and other infections of the female reproductive system.
Danish: De hyppigste bivirkninger ved Steglujan (som kan forekomme hos mere end 1 ud af 10 patienter) er svampeinfektion i skeden og andre infektioner i de kvindelige kønsorganer.
English: Steglujan is available as tablets in 2 strengths of ertugliflozin and sitagliptin (5 mg/100 mg and 15 mg/100 mg) and can only be obtained with a prescription.
Danish: Steglujan fås som tabletter i 2 styrker af ertugliflozin og sitagliptin (5 mg/100 mg og 15 mg/100 mg) og udleveres kun efter recept.
English: These hormones stimulate the pancreas to produce insulin.
Danish: Disse hormoner stimulerer bugspytkirtlen til at producere insulin.
English: The second study found that adding ertugliflozin to a combination of sitagliptin and metformin was more effective than placebo (a dummy treatment).
Danish: Den anden undersøgelse viste, at tilføjelse af ertugliflozin til en kombination af sitagliptin og metformin var mere effektivt end placebo (uvirksom behandling).
English: The benefits of Steglujan were lower in patients with kidney problems.
Danish: Fordelene ved Steglujan var mindre hos patienter med nyreproblemer.
English: Side effects reported with Steglujan are carefully evaluated and any necessary action taken to protect patients.
Danish: Indberettede bivirkninger ved Steglujan vurderes omhyggeligt, og der tages i givet fald de nødvendige forholdsregler for at beskytte patienterne.
English: The first study, in patients who were all taking metformin, compared the combination of ertugliflozin and sitagliptin with ertugliflozin or sitagliptin on their own.
Danish: I den første undersøgelse, der omfattede patienter, som alle tog metformin, sammenlignedes kombinationen af ertugliflozin og sitagliptin med ertugliflozin eller sitagliptin alene.
English: Treatment with Steglujan also led to weight loss, which is considered beneficial in patients with diabetes.
Danish: Behandling med Steglujan medfører desuden et vægttab, der anses for gavnligt hos diabetespatienter.
English: The recommended starting dose is one 5 mg/100 mg tablet taken once a day.
Danish: Den anbefalede startdosis er én 5 mg/100 mg-tablet én gang dagligt.
English: • patients whose blood glucose levels are not satisfactorily controlled with the diabetes medicines metformin and/or a sulphonylurea, in combination with either ertugliflozin or sitagliptin;
Danish: • patienter, hvis blodsukkerniveau ikke er tilstrækkeligt reguleret med diabetes-midlerne metformin og/eller et sulfonylurinstof i tillæg til enten ertugliflozin eller sitagliptin
English: Sitagliptin blocks the breakdown of incretin hormones in the body.
Danish: Sitagliptin blokerer nedbrydningen af inkretinhormoner i kroppen.
English: Three main studies, involving 1,987 patients showed that Steglujan was effective at lowering blood glucose levels in patients with type 2 diabetes, as measured by the decrease in blood levels of HbA1c (a measure of blood glucose) after 6 months of treatment.
Danish: Tre hovedundersøgelser med i alt 1.987 patienter har påvist, at Steglujan er effektivt til at sænke blodsukkerniveauet hos patienter med type 2-diabetes som målt ved et fald i niveauet af HbA1c i blodet (blodsukkermåling) efter 6 måneders behandling.
English: Type 2 diabetes is a disease in which the body does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively.
Danish: Type 2-diabetes er en sygdom, hvor kroppen enten ikke producerer nok insulin til at regulere blodsukkeret, eller hvor kroppen ikke anvender insulinet effektivt.
English: Regarding safety, this was considered in line with that of other medicines of the same class.
Danish: Sikkerhedsprofilen for Steglujan anses for at være på linje med sikkerhedsprofilen for andre lægemidler af samme klasse.
English: Steglujan is a medicine used to control blood glucose (sugar) levels in adults with type 2 diabetes.
Danish: Steglujan er et lægemiddel, der anvendes til at regulere niveauet af blodsukker (glukose) hos voksne med type 2-diabetes.
English: HbA1c levels fell by between 0.8 and 0.9 points, compared with a fall of 0.1 with placebo.
Danish: HbA1c-niveauet faldt med 0,8-0,9 point sammenholdt med et fald på 0,1 ved placebo.
English: Treatment with the combination of ertugliflozin and sitagliptin lowered HbA1c levels by up to 1.5 percentage points, compared with reductions of up to 1.1 for ertugliflozin and for sitagliptin on their own.
Danish: Behandling med kombinationen af ertugliflozin og sitagliptin sænkede HbA1c-niveauet med op til 1,5 procentpoint sammenholdt med en reduktion på op til 1,1 procentpoint for ertugliflozin og sitagliptin alene.
English: It does this by blocking a protein in the kidneys (called SGLT2) that normally takes glucose back into the blood from the kidneys.
Danish: Det virker ved at blokere et protein i nyrerne (SGLT2), der normalt transporterer glukose tilbage fra urinen til blodbanen.
English: For the full list of side effects and restrictions with Steglujan, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Steglujan fremgår af indlægssedlen.
English: This study found that adding Steglujan to diet and exercise was much more effective than placebo, with HbA1c levels falling by between 1.6 and 1.7 points with the combination of ertugliflozin and sitagliptin compared with a fall of 0.4 points with placebo.
Danish: Denne undersøgelse fandt, at tilføjelse af Steglujan til kost og motion var meget mere effektivt end placebo, idet HbA1c-niveauet faldt med 1,6-1,7 point med kombinationen af ertugliflozin og sitagliptin sammenholdt med et fald på 0,4 point med placebo.
English: The third study compared Steglujan with placebo in patients who were not taking other diabetes medicines and in whom diet and exercise were not enough to control their blood sugar levels.
Danish: I den tredje undersøgelse sammenlignedes Steglujan med placebo hos patienter, der ikke fik andre diabetesmidler, og som ikke opnåede tilstrækkelig regulering af deres blodsukkerniveau med kost og motion.
English: Sitagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon.
Danish: Sitagliptin nedsætter desuden leverens produktion af glukose ved at øge insulinniveauet og sænke niveauet af hormonet glukagon.
English: Together, these actions reduce blood glucose levels and help to control type 2 diabetes.
Danish: Tilsammen nedsætter disse virkninger blodsukkeret og forbedrer reguleringen af type 2-diabetes.
English: How is Steglujan used?
Danish: Hvordan anvendes Steglujan?
English: Prolonging the action of incretin hormones makes the pancreas produce more insulin when blood glucose levels are high.
Danish: Forlængelse af virkningen af inkretinhormoner i blodet får bugspytkirtlen til at producere mere insulin, når blodsukkerniveauet er højt.
English: Steglujan was shown to be effective at controlling blood glucose levels.
Danish: Det er påvist, at Steglujan er effektivt til at regulere blodsukkerniveauet.
English: In addition, the results indicated that treatment with Steglujan was associated with a beneficial reduction in body weight.
Danish: Derudover viste resultaterne, at Steglujan medførte et gavnligt vægttab.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Steglujan have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Steglujan.
English: The result is a high level of glucose in the blood.
Danish: Dette medfører et højt blodsukkerniveau.
English: What benefits of Steglujan have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Steglujan?
English: The two active substances in Steglujan work in different ways to lower glucose levels:
Danish: De to aktive stoffer i Steglujan sænker blodsukkerniveauet på hver sin måde:
English: Ertugliflozin helps to lower blood glucose by making the patient pass out glucose in the urine.
Danish: Ertugliflozin hjælper med at sænke blodsukkerniveauet ved at få nyrerne til at udskille blodsukker (glukose) i urinen.
English: How does Steglujan work?
Danish: Hvordan virker Steglujan?
English: 1 g / 0.5 g Powder for concentrate for solution for infusion
Danish: 1 g / 0,5 g Pulver til koncentrat til infusionsvæske, opløsning
English: Strength Pharmaceutical form
Danish: Styrke Lægemiddelform Administration Emballage Pakningsstørrelse
English: 10 vials
Danish: Hætteglas (glas) 10 hætteglas
English: These measures will help protect the environment.
Danish: Dette vil hjælpe med at beskytte miljøet.
English: You will not give yourself this medicine.
Danish: Du kommer ikke til at give dig selv dette lægemiddel.
English: This does not rule out more direct countermeasures.
Danish: Dette udelukker ikke mere direkte modforanstaltninger.