FrancophonIA/ELRC3.0 huggingface dataset:
English: The efficacy of Velactis in reducing the risk of new intramammary infections during the dry period when administered concomitantly with antimicrobial treatment to cows with intramammary infections has not been investigated compared to antimicrobial treatment alone.
Danish: Effekten af Velactis på reduktion af risikoen for nye intramammære infektioner i goldperioden ved samtidig administration af antimikrobiel behandling af køer med intramammære infektioner i forhold til køer der udelukkende har modtaget antimikrobiel behandling, er ikke undersøgt.
English: For the 25 ml, 50 ml and the 5x5ml only: Once broached, use within 28 days.
Danish: For 25 ml, 50 ml og 5x5 ml: Efter åbning anvend inden 28 døgn.
English: In case of accidental self-injection, seek medical advice, and show the package leaflet or the label to the physician.
Danish: I tilfælde af selvinjektion ved et uheld, søg læge, og vis indlægssedlen eller etiketten til lægen.
English: Velactis should be used as part of a comprehensive mastitis and milk quality control program under veterinarian advice which might include the need to use intramammary treatment.
Danish: Velactis bør anvendes som et element i et mere omfattende mastitis- og mælkekvalitetsprogram efter dyrlægens anvisninger, som også kan inkludere behovet for anvendelse af intramammære behandlinger.
English: Cabergoline should not enter surface waters as it has harmful effects on aquatic species.
Danish: Cabergolin bør ikke udledes til overfladevand, da det har skadelige effekter på akvatiske organismer.
English: Cattle (dairy cows)
Danish: Kvæg (malkekøer)
English: It acts on dopamine receptors of prolactin producing cells in the pituitary gland suppressing the prolactin production and leading to the inhibition of prolactin secretion dependent process.
Danish: Det virker på dopaminreceptorer på prolaktinproducerende celler i hypofysen, begrænser derved prolaktinproduktionen og fører til hæmning af den prolaktinsekretoriske afhængige proces.
English: Therefore, Velactis-treated cows should not be allowed to have access to open water, and should not contaminate watercourses with faeces until at least 5 days after administration.
Danish: Derfor bør køer behandlet med Velactis ikke have adgang til naturlige vandkilder, og bør ikke have mulighed for at forurene vandkilder med fæces før tidligst 5 døgn efter administration.
English: Subsequently udder pain and discomfort are reduced at one and two days after drying off, respectively.
Danish: Som en følge heraf reduceres hhv. yversmerte og ubehaget i 1-2 døgn efter goldning.
English: For cows considered likely to be free of subclinical mastitis at drying off, in which antibiotic use is not justified/permitted, Velactis can be used as a dry cow treatment.
Danish: Hos køer som forventes at være fri for subklinisk mastitis ved goldning, i hvilke brug af antibiotika ikke er berettiget/tilladt, kan Velactis anvendes som en afgoldningsbehandling.
English: Due to its pharmacological effect (inhibition of lactation) breastfeeding women should avoid contact with the product.
Danish: Som følge af stoffets farmakologiske effekt (hæmning af mælkeproduktion) bør ammende kvinder undgå kontakt med produktet.
English: ADVICE ON CORRECT ADMINISTRATION Normal aseptic procedures for administration of an intramuscular injection should be followed.
Danish: OPLYSNINGER OM KORREKT ANVENDELSE Normale aseptiske procedurer mht. administration af intramuskulære injektioner bør overholdes.
English: The veterinary medicinal product may cause skin sensitization.
Danish: Dette veterinære lægemiddel kan forårsage hudreaktioner.
English: Cabergoline Bovine 0.10 µg/kg 0.25 µg/kg
Danish: Cabergolin Kvæg 0.10 µg/kg µg/kg µg/kg µg/kg µg/kg
English: In the absence of data on pregnancy outcome in humans following injection of cabergoline, pregnant women and women attempting to conceive should avoid contact with the product.
Danish: Der findes ingen data om påvirkning af graviditet hos mennesker efter injektion af cabergolin, og derfor bør gravide kvinder, og kvinder der forsøger at blive gravide, undgå kontakt med produktet.
English: Meat and offal: 23 days Milk: - Zero hours after calving when the dry period length is 32 days or more.
Danish: Slagtning: 23 døgn Mælk: - Nul timer efter kælvning ved en goldperiode på 32 døgn eller mere.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) 1.12 mg/ml
Danish: MÆNGDEN AF AKTIVT STOF (AKTIVE STOFFER) 1,12 mg/ml
English: The difference between groups was 13.7% (95% confidence interval 6.4-21%).
Danish: Forskellen mellem grupperne var 13,7 % (95 % konfidensinterval 6,4-21 %).
English: Clear pale yellow solution.
Danish: Klar, svagt gul opløsning.
English: However, administration of tylosin concomitantly with Velactis in cows did not show any changes of cabergoline pharmacokinetic properties.
Danish: Imidlertid har samtidig behandling af køer med tylosin og Velactis ikke vist ændringer af cabergolins farmakokinetiske egenskaber.
English: In vitro, some macrolide antibiotics, like erythromycin, inhibited the activity of bovine Cytochrom P 450-enzymes (CYP3A4-subclass).
Danish: In vitro inhiberer visse makrolidantibiotika, f.eks. erythromycin, aktiviteten af bovin Cytochrom P 450-enzymer (CYP3A4-underklasse).
English: Interactions with other medicinal products and other forms of interaction In vitro, some macrolide antibiotics like erythromycin inhibited the activity of bovine Cytochrom P 450-enzymes (CYP3A4-subclass).
Danish: Interaktion med andre lægemidler og andre former for interaktion In vitro inhiberer visse makrolidantibiotika, f.eks. erythromycin, aktiviteten af bovin Cytochrom P 450-enzymer (CYP3A4-underklasse).
English: In the same study, incidence of milk leakage was significantly lower among Velactis treated animals (2.0%) as compared to placebo treated animals (10.7%).
Danish: I det samme studie, fandtes incidens af mælkeløb signifikant lavere hos Velactis-behandlede dyr (2,0 %) sammenlignet med placebo-behandlede dyr (10,7 %).
English: Cardboard box with 1 vial of 5 ml, 25 ml or 50 ml, or 5 vials of 5 ml.
Danish: Papæske med 1 hætteglas á 5 ml, 25 ml eller 50 ml, eller 5 hætteglas á 5 ml.
English: The difference between groups was 8.7% (95% confidence interval 4.9-12.6%).
Danish: Forskellen mellem grupperne var 8,7 % (95 % konfidensinterval 4,9-12,6 %).
English: In a multicentric randomized clinical trial where dairy cows with no intramammary infections at the time of drying-off were administered either Velactis or placebo at the time of drying-off, the incidence of new intramammary infections within 7 days after subsequent calving was significantly lower among udder quarters of cows treated with Velactis (20.5%) as compared to placebo (26.0%).
Danish: I en multicenter, randomiseret klinisk undersøgelse hvor malkekøer uden intramammære infektioner på tidspunktet for goldning blev behandlet enten med Velactis eller placebo ved goldning, fandtes incidensen af nye intramammære infektioner indtil 7 dage efter den følgende kælvning at være signifikant lavere i yverkirtler fra køer behandlet med Velactis (20,5 %) i forhold til køer behandlet med placebo (26,0 %).
English: Persons with a known hypersensitivity to cabergoline or any of the excipients should avoid contact with the veterinary medicinal product.
Danish: Personer med kendt overfølsomhed for cabergoline eller et eller flere af hjælpestofferne bør undgå kontakt med dette veterinære lægemiddel.
English: Therefore, the product should only be administered to dairy cows at the time of drying-off.
Danish: Produktet bør derfor kun administreres til malkekøer ved goldning.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Label of 5 ml vial
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER 5 ml Hætteglas
English: Special precautions for use in animals The product should only be used in dairy cows at the time of drying-off.
Danish: Særlige forsigtighedsregler for dyret Lægemidlet bør kun anvendes til malkekøer ved goldning.
English: In a randomized and placebo controlled clinical study Velactis treated cows presented less signs of udder pain in comparison with controls on the first two days after drying-off.
Danish: I en randomiseret og placebo-kontrolleret klinisk undersøgelse viste Velactis-behandlede køer mindre tegn på yversmerte i forhold til kontrolgruppen i de første to døgn efter goldning.
English: The recommended dose is 5.6 mg of cabergoline (corresponding to 5 ml of solution for injection) per animal in one single injection at the day of drying-off after the last milking.
Danish: Den anbefalede dosering er 5,6 mg cabergolin (svarer til 5 ml opløsning til injektion) pr. dyr, som én enkelt injektion efter den sidste udmalkning inden goldning.
English: This was confirmed in another multicentric randomized clinical trial where incidence of milk leakage was significantly lower among Velactis treated animals (3.9%) as compared to placebo treated animals (17.6%).
Danish: Dette blev bekræftet i en anden multicenter randomiseret klinisk undersøgelse, hvor incidens af mælkeløb var signifikant lavere hos Velactis-behandlede dyr (3,9 %) i forhold til placebo-behandlede dyr (17,6 %).
English: CONTRAINDICATIONS Do not use in case of hypersensitivity to cabergoline or to any of the excipients.
Danish: KONTRAINDIKATIONER Må ikke anvendes i tilfælde af overfølsomhed for cabergolin eller ét eller flere af hjælpestofferne.
English: Do not use after the expiry date which is stated on the carton after EXP.
Danish: Dette veterinærlægemiddel må ikke anvendes efter udløbsdatoen anført på æsken efter EXP. Udløbsdatoen refererer til sidste dag i måneden.
English: The difference in percentage of new intramammary infections during the dry period between Velactis treated animals and the placebo group was 5.5% (95% confidence interval 0.5-10.4%).
Danish: Forskellen i procent af nye intramammære infektioner i goldperioden mellem dyr behandlet med Velactis eller med placebo var 5,5 % (95 % konfidensinterval 0,5-10,4 %).
English: The recommended dose is 5.6 mg of cabergoline (corresponding to 5 ml of Velactis) per animal in one single injection at the day of drying-off after the last milking.
Danish: Den anbefalede dosering er 5,6 mg cabergolin (svarer til 5 ml Velactis) pr. dyr, som én enkelt injektion efter den sidste udmalkning inden goldning.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intramuscular use
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Intramuskulær anvendelse.
English: The difference in occurrence of pain was 9.9% (95% confidence interval 4.0-15.8%) between the Velactis treated cows compared to placebo treated animals.
Danish: Forskellen i forekomsten af smerte var 9,9 % (95% konfidensinterval 4,0-15,8 %) mellem de Velactis-behandlede køer og de placebo-behandlede dyr.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each ml contains 1.12 mg of cabergoline.
Danish: ANGIVELSE AF DE(T) AKTIVE STOF(FER) OG ANDRE INDHOLDSSTOFFER Hver ml indeholder 1,12 mg cabergolin.
English: Dimethyl sulfoxide Triglycerides, medium-chain
Danish: Triglycerider, medium-kæder
English: In a randomized and placebo controlled clinical study, reduced discomfort was demonstrated during the first day after drying-off by increasing daily lying time by 143 +/- 17 minutes in Velactis treated animals in comparison with untreated controls.
Danish: I en randomiseret og placebo-kontrolleret klinisk undersøgelse, viste dyr i den Velactis-behandlede gruppe mindre ubehag i det første døgn efter goldning målt ved en længere daglig liggetid på 143 +/- 17 minutter sammenlignet med den ubehandlede kontrolgruppe.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES 1 ml contains 1.12 mg of cabergoline.
Danish: ANGIVELSE AF AKTIVE STOFFER OG ANDRE STOFFER 1 ml indeholder 1,12 mg cabergolin
English: TARGET SPECIES Cattle (dairy cows)
Danish: DYREARTER Kvæg (malkekøer)
English: Use during pregnancy, lactation or lay
Danish: Drægtighed, diegivning eller æglægning
English: Do not use in case of hypersensitivity to cabergoline or to any of the excipients.
Danish: Må ikke anvendes i tilfælde af overfølsomhed for cabergolin eller ét eller flere af hjælpestofferne.
English: The product should only be used in dairy cows at the time of drying-off.
Danish: Lægemidlet bør kun anvendes til malkekøer ved goldning.
English: Target tissues
Danish: Dimethylsulfoxid
English: PACKAGE LEAFLET FOR Velactis 1.12 mg/ml solution for injection for cattle.
Danish: INDLÆGSSEDDEL TIL: Velactis 1,12 mg/ml opløsning til injektion til kvæg.
English: Prolactin inhibitor
Danish: Prolaktinhæmmer
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Velactis 1.12 mg/ml solution for injection for cattle.
Danish: VETERINÆRLÆGEMIDLETS NAVN Velactis 1,12 mg/ml opløsning til injektion til kvæg.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Velactis 1.12 mg/ml solution for injection cabergoline
Danish: VETERINÆRLÆGEMIDLETS NAVN Velactis 1,12 mg/ml opløsning til injektion cabergolin
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Velactis 1.12 mg/ml solution for injection for cattle
Danish: VETERINÆRLÆGEMIDLETS NAVN Velactis 1,12 mg/ml opløsning til injektion til kvæg
English: Label of 25 ml vial
Danish: Kartonæske med 25 ml hætteglas
English: Label of 50 ml vial
Danish: Kartonæske med 50 ml hætteglas
English: cabergoline
Danish: Cabergolin
English: Cabergoline
Danish: cabergolin
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Velactis 1.12 mg/ml solution for injection for cattle (dairy cows).
Danish: VETERINÆRLÆGEMIDLETS NAVN Velactis 1,12 mg/ml opløsning til injektion til kvæg (malkekøer) cabergolin
English: The European Commission granted a marketing authorisation valid throughout the European Union for Emend on 11 November 2003.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Emend den 11. november 2003.
English: Other information about Emend
Danish: Andre oplysninger om Emend
English: The full EPAR for Emend can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Emend findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This is a summary of the European public assessment report (EPAR) for Emend.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Emend.
English: A risk management plan has been developed to ensure that Emend is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Emend anvendes så sikkert som muligt.
English: What measures are being taken to ensure the safe and effective use of Emend?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Emend?
English: The dose of Emend oral suspension to be given depends on the patient's bodyweight.
Danish: Dosen af oral Emend-suspension, der skal gives, er baseret på patientens kropsvægt.
English: What is the risk associated with Emend?
Danish: Hvilken risiko er der forbundet med Emend?
English: Emend is a neurokinin 1 (NK1) receptor antagonist.
Danish: Emend er en neurokinin 1 (NK1)-receptorantagonist.
English: When substance P attaches to these receptors, it causes nausea and vomiting.
Danish: Når substans P binder sig til disse receptorer, forårsager det kvalme og opkastning.
English: It stops a chemical in the body (substance P) from binding to the NK1 receptors.
Danish: Den forhindrer et kemisk stof i kroppen (substans P) i at binde sig til NK1-receptorerne.
English: Emend 80 mg and 125 mg must not be taken with the following medicines:
Danish: Emend 80 mg og 125 mg må ikke tages sammen med følgende lægemidler:
English: Emend is a medicine containing the active substance aprepitant.
Danish: Emend er et lægemiddel, der indeholder det aktive stof aprepitant.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Emend.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Emend.
English: • cisapride (used to relieve certain stomach problems).
Danish: • cisaprid (anvendes til lindring af visse maveproblemer).
English: For more information about treatment with Emend, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Emend, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: This is nausea and vomiting that a patient can experience after surgery.
Danish: Dette er kvalme og opkastning, som en patient kan opleve efter kirurgiske indgreb.
English: In children between 6 months and 12 years of age, Emend oral suspension is given together with a 5HT3 antagonist.
Danish: Hos børn mellem 6 måneder og 12 år gives Emend som oral suspension sammen med en 5-HT3antagonist.
English: The CHMP decided that Emend's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Emend opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Emend.
English: • pimozide (used to treat mental illness);
Danish: • pimozid (anvendes til behandling af psykiske sygdomme)
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Emend, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Emend, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
English: All three studies compared the effectiveness of Emend, taken in combination with dexamethasone and ondansetron, with that of the standard combination of dexamethasone and ondansetron.
Danish: Alle tre undersøgelser sammenlignede virkningen af Emend, taget i kombination med dexamethason og ondansetron, med standardkombinationen af dexamethason og ondansetron.
English: In children, the most common side effects are hiccups and flushing.
Danish: Hos børn er de hyppigste bivirkninger hikke og rødme.
English: After chemotherapy, one 80 mg capsule is taken each day for the next two days.
Danish: Efter kemoterapien indtages én kapsel på 80 mg hver dag i de to efterfølgende dage.
English: Emend was also shown to be effective in the first 24 hours after chemotherapy.
Danish: Det blev også påvist, at Emend var effektivt i de første 24 timer efter kemoterapi.
English: Emend oral suspension is given one hour before the start of chemotherapy, and for the next 2 days.
Danish: Den orale Emend-suspension gives én time før påbegyndelse af kemoterapi og i de to følgende dage.
English: The most common side effect of Emend at all doses in adults (seen in between 1 and 10 patients in 100) is increased liver enzymes.
Danish: Den hyppigste bivirkning ved Emend hos voksne ved alle doser (som optræder hos mellem 1 og 10 patienter ud af 100) er forhøjede antal leverenzymer.
English: In the chemotherapy studies in adults, adding Emend to the standard combination was more effective than the standard combination alone.
Danish: I kemoterapiundersøgelserne hos voksne var det mere effektivt at anvende Emend som tillægsbehandling til standardkombinationen end standardkombinationen alene.
English: It is only given on the first day of the chemotherapy and is followed by treatment involving a corticosteroid and a 5HT3 antagonist.
Danish: Det gives kun på kemoterapibehandlingens første dag og efterfølges af behandling, der omfatter en kortikosteroid og en 5-HT3-antagonist.
English: • terfenadine, astemizole (commonly used to treat allergy symptoms - these medicines may be available without a prescription);
Danish: • terfenadin og astemizol (anvendes almindeligvis til behandling af allergisymptomer - disse lægemidler kan udleveres uden recept)
English: In chemotherapy, three main studies have been carried out for Emend 80 and 125 mg capsules.
Danish: I forbindelse med kemoterapi blev der gennemført tre hovedundersøgelser for Emend 80- og 125 mgkapsler.
English: Emend 40 mg capsules are used to prevent postoperative nausea and vomiting (PONV) in adults.
Danish: Emend-kapsler, 40 mg, anvendes til at forebygge postoperativ kvalme og opkastning (PONV) hos voksne.
English: The studies measured how many patients had a complete response, which was defined as no vomiting and no need for any other medication to control nausea and vomiting in the 24 hours after the operation.
Danish: Undersøgelserne målte, hvor mange patienter der havde komplet respons, hvilket blev defineret som ingen opkastning og intet behov for anden medicin for at holde kvalmen og opkastningen under kontrol inden for 24 timer efter operationen.
English: The first two studies involved a total of 1,094 adults receiving chemotherapy including cisplatin, and the third involved 866 adults with breast cancer who were receiving cyclophosphamide, with or without doxorubicin or epirubicin.
Danish: De første to undersøgelser omfattede i alt 1 094 voksne, som fik kemoterapi med cisplatin, og den tredje omfattede 866 voksne patienter med brystkræft, der fik cyclofosfamid, med eller uden doxorubicin eller epirubicin.
English: What is Emend?
Danish: Hvad er Emend?
English: Tests were performed to determine that Emend 165 mg produces the same amount of aprepitant in the body as a single dose of 150 mg Ivemend.
Danish: Der blev gennemført test for at fastslå, at Emend 165 mg fremstiller den samme mængde aprepitant i kroppen som en enkeltdosis af 150 mg Ivemend.
English: By blocking the receptors, Emend can prevent nausea and vomiting, which often happens after chemotherapy or as a complication of surgery.
Danish: Ved at blokere receptorerne kan Emend forhindre den kvalme og opkastning, som ofte indtræder efter kemoterapi eller som en komplikation efter kirurgiske indgreb.
English: The effectiveness of Emend was also seen during a further five cycles of chemotherapy.
Danish: Virkningen af Emend blev også undersøgt i yderligere fem kemoterapiforløb.
English: Why has Emend been approved?
Danish: Hvorfor blev Emend godkendt?
English: It must be given with other medicines that also prevent nausea and vomiting, including a corticosteroid (such as dexamethasone) and a ‘5-HT3 antagonist' (such as ondansetron).
Danish: Lægemidlet skal gives sammen med andre lægemidler, som også forebygger kvalme og opkastning, bl.a. et kortikosteroid (f.eks. dexamethason) og en "5-HT3-antagonist" (f.eks. ondansetron).
English: The main measure of effectiveness was the number of patients who had no nausea and vomiting in the five days after receiving chemotherapy.
Danish: Det primære effektmål var antallet af patienter, der ikke oplevede kvalme og opkastning i de første fem dage efter at have fået kemoterapi.
English: Emend 165 mg is given to adults only once, one hour before the start of chemotherapy.
Danish: Emend 165 mg til voksne gives kun én gang én time, før kemoterapien påbegyndes.
English: Emend is used with other medicines to prevent nausea and vomiting caused by chemotherapy (medicines used to treat cancer).
Danish: Emend anvendes sammen med andre lægemidler til at forebygge kvalme og opkastning forårsaget af kemoterapi (lægemidler, der anvendes til behandling af kræft).