FrancophonIA/ELRC3.0 huggingface dataset:
English: When Vectormune ND is given to chickens or eggs, the animals' immune system recognises the virus as ‘foreign' and makes antibodies against it.
Danish: Når Vectormune ND gives til kyllinger eller i æg, registrerer dyrenes immunsystem virusset som "fremmed" og reagerer ved at danne antistoffer mod det.
English: What is Vectormune ND and what is it used for?
Danish: Hvad er Vectormune ND, og hvad anvendes det til?
English: Other information about Vectormune ND
Danish: Andre oplysninger om Vectormune ND
English: There are no known side effects with Vectormune ND.
Danish: Der er ingen kendte bivirkninger ved Vectormune ND.
English: ND is a viral infection of chickens which causes gasping and coughing, nervous signs (drooping wings, twisting of the head and neck, circling and paralysis), swelling of the tissues around the eyes and neck, greenish watery diarrhoea and reduced egg production.
Danish: Newcastle disease hos kyllinger er en virussygdom, der forårsager vejrtrækningsbesvær og hoste, symptomer fra nervesystemet (hængende vinger, drejning af hoved og hals, cirkelbevægelser og lammelse), hævelse af vævet omkring øjne og hals, grønlig, vandig diarré og nedsat ægproduktion.
English: Why is Vectormune ND approved?
Danish: Hvorfor er Vectormune ND blevet godkendt?
English: The vaccine can be given to one-day-old chicks as a single injection under the skin or directly into 18-day-old eggs containing embryos (unhatched developing chicks).
Danish: Vaccinen kan gives til daggamle kyllinger som en enkelt injektion under huden eller direkte i 18 dage gamle æg med ikkeudklækkede fostre under udvikling.
English: It is not intended to provide practical advice on how to use Vectormune ND.
Danish: Det er ikke en praktisk vejledning i, hvordan Vectormune ND bør anvendes.
English: Chickens become infected at an early age via inhalation of dander (flakes of skin) containing the virus which can remain infectious for several months after being shed from the body.
Danish: Kyllingerne bliver inficeret i en tidlig alder ved indånding af skæl fra huden, som indeholder virus og kan forblive smittefarligt i flere måneder efter at være afdrysset fra kroppen.
English: What are the risks associated with Vectormune ND?
Danish: Hvilke risici er der forbundet med Vectormune ND?
English: Safety information has been included in the summary of product characteristics and the package leaflet for Vectormune ND, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
Danish: Der er anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Vectormune ND, herunder passende forholdsregler, som skal følges af sundhedspersoner og den, der er ejer af eller ansvarlig for dyret.
English: The active substance in Vectormune ND is a turkey herpesvirus (rHVT/ND) that does not cause disease in chickens and has been modified so that it also produces one of the proteins of a strain of Newcastle disease virus (D-26 lentogenic strain).
Danish: Det aktive stof i Vectormune ND er et kalkunherpesvirus (rHVT/Newcastle Disease), der ikke medfører sygdom hos kyllinger og er blevet modificeret, således at det også producerer et af proteinerne i en Newcastle disease-stamme (lentogen stamme D-26).
English: Twenty-two Vectormune ND vaccinated day-old layer chickens from this study were challenged at day 21 in the laboratory with ND strain and had no clinical signs for up to 2 weeks after challenge while all of 12 unvaccinated birds used for comparison died.
Danish: 22 Vectormune ND-vaccinerede daggamle kyllinger til æglægning fra denne undersøgelse blev på dag 21 i laboratoriet belastet med en Newcastle disease-stamme og udviste ingen kliniske tegn i op til to uger efter belastningen, mens alle de 12 uvaccinerede fugle, der blev brugt til sammenligning, døde.
English: Since no natural outbreaks of ND and MD occurred the chickens were challenged (exposed to infection) in the laboratory.
Danish: Da der ikke forekom naturlige udbrud af Newcastle disease eller Mareks sygdom, blev kyllingerne belastet (udsat for smitte) i laboratoriet.
English: Vectormune ND is a veterinary vaccine used to protect chickens against Newcastle disease (ND) and Marek's disease (MD).
Danish: Vectormune ND er en veterinær vaccine til beskyttelse af kyllinger mod Newcastle disease og Mareks sygdom.
English: For MD protection starts at one week of age and lasts for the risk period of infection with MD.
Danish: Beskyttelsen mod Mareks sygdom begynder i alderen én uge og varer i hele risikoperioden for infektion med Mareks sygdom.
English: MD is a herpesvirus infection of chickens which can cause paralysis of the wings and legs and causes tumours in various organs.
Danish: Mareks syge hos kyllinger er en herpesvirusinfektion, som kan medføre lammelse af vinger og ben, og som forårsager tumorer i forskellige organer.
English: The modified turkey herpesvirus in Vectormune ND is closely related to MD herpesvirus and will also produce the fusion protein which forms part of the outer coat of ND virus.
Danish: Det modificerede kalkunherpesvirus i Vectormune ND er nært beslægtet med Mareks sygdomsvirus og producerer også det fusionsprotein, der danner den ydre kapsel af Newcastle disease-virus.
English: Vectormune ND is available as a suspension and solvent to be made into a suspension for injection and can only be obtained with a prescription.
Danish: Vectormune ND fås som en suspension med solvens, hvoraf der fremstilles en suspension til injektion.
English: In a third field study around 10,000 one-day-old layer chickens were vaccinated with Vectormune ND and a similar number with a vaccine against ND alone.
Danish: I en tredje feltundersøgelse blev ca. 10 000 daggamle kyllinger til æglægning vaccineret med Vectormune ND og et tilsvarende antal med en vaccine mod Newcastle disease alene.
English: Birds infected with MD virus can be carriers and shedders of the virus for life.
Danish: Fugle, der er smittet med Mareks sygdomsvirus, kan bære og udskille virussen for livstid.
English: In the second field study, a group of 18-day-old eggs containing embryos and a group of one-day-old chicks were vaccinated with Vectormune ND.
Danish: I den anden feltundersøgelse blev en gruppe 18 dage gamle æg indeholdende fostre og en gruppe daggamle kyllinger vaccineret med Vectormune ND.
English: For ND protection starts at 3 weeks of age and lasts until 9 weeks of age for broilers (chickens bred for meat) and 18 weeks of age for layers (chickens bred for egg production).
Danish: Beskyttelsen mod Newcastle disease begynder i 3-ugersalderen og varer indtil 9-ugersalderen hos slagtekyllinger og 18-ugersalderen hos kyllinger til æglægning.
English: How does Vectormune ND work?
Danish: Hvordan virker Vectormune ND?
English: In the first field study a group of 18-day-old eggs containing embryos and a group of one-day-old chicks were vaccinated with Vectormune ND.
Danish: I den første feltundersøgelse blev en gruppe 18 dage gamle æg indeholdende fostre og en gruppe daggamle kyllinger vaccineret med Vectormune ND.
English: How is Vectormune ND used?
Danish: Hvordan anvendes Vectormune ND?
English: For more information about treatment with Vectormune ND, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker yderligere oplysninger om behandling med Vectormune ND, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: For practical information about using Vectormune ND, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker praktisk vejledning om anvendelsen af Vectormune ND, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: What benefits of Vectormune ND have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Vectormune ND?
English: Five-week-old chickens from the vaccinated eggs were challenged with ND virus and 91% of vaccinated chickens were protected compared with no protection in the unvaccinated group.
Danish: Fem uger gamle kyllinger fra de vaccinerede æg blev belastet med Newcastle disease-virus, og 91 % af de vaccinerede kyllinger opnåede beskyttelse, sammenholdt med ingen beskyttelse i den uvaccinerede gruppe.
English: Four-week-old chickens from vaccinated eggs were challenged with ND virus and 86% of the chickens were protected compared with 0-10% in the unvaccinated group.
Danish: Fire uger gamle kyllinger fra vaccinerede æg blev belastet med Newcastle disease-virus, og 86 % af de vaccinerede kyllinger opnåede beskyttelse, sammenholdt med 0-10 % i den uvaccinerede gruppe.
English: Nine-dayold broilers from the chicks vaccinated at one-day-old were challenged with MD virus and Vectormune ND provided protection to 90% of the chickens compared with 9-12% in the unvaccinated group.
Danish: Ni dage gamle slagtekyllinger fra den gruppe, der var blevet vaccineret som daggamle, blev belastet med Mareks sygdom-virus, og Vectormune ND gav beskyttelse af 90 % af kyllingerne, sammenholdt med 9-12 % i den uvaccinerede gruppe.
English: Nine-day-old broilers from vaccinated eggs were challenged with MD virus and 85% of the chickens were protected compared with 9% in the unvaccinated group.
Danish: Ni dage gamle slagtekyllinger fra vaccinerede æg blev belastet med Mareks sygdomsvirus, og 85 % af kyllingerne opnåede beskyttelse, sammenholdt med 9 % i den uvaccinerede gruppe.
English: Five-week-old chickens from the vaccinated one-day-old chicks were challenged with ND virus and 81% of vaccinated chickens were protected compared with no protection in the unvaccinated group.
Danish: Fem uger gamle kyllinger fra den gruppe, der var blevet vaccineret som daggamle, blev belastet med Newcastle disease-virus, og 81 % af de vaccinerede kyllinger opnåede beskyttelse, sammenholdt med ingen beskyttelse i den uvaccinerede gruppe.
English: Nineday-old broilers from the group of chicks vaccinated at one-day-old were challenged with MD virus and 82% of the chickens were protected compared with 12% in the unvaccinated group.
Danish: Ni dage gamle slagtekyllinger fra den gruppe, der var blevet vaccineret som daggamle, blev belastet med Mareks sygdomsvirus, og 82 % af kyllingerne opnåede beskyttelse, sammenholdt med 12 % af de uvaccinerede.
English: Nine-day-old chickens from vaccinated eggs were challenged with MD virus and 88% of the chickens were protected compared with 9-12% in the unvaccinated group.
Danish: Ni dage gamle kyllinger fra vaccinerede æg blev belastet med Mareks sygdomsvirus, og 88 % af kyllingerne opnåede beskyttelse, sammenholdt med 9-12 % i den uvaccinerede gruppe.
English: This will help protect the chickens against ND and MD.
Danish: Dette beskytter kyllingerne mod Newcastle disease og Mareks sygdom.
English: Four-week-old chickens from the group of one-day-old vaccinated chicks were challenged with ND virus and Vectormune ND provided protection in 95% of the chickens compared with 0-10% in the non-vaccinated group.
Danish: Fire uger gamle kyllinger fra den gruppe, der var blevet vaccineret som daggamle, blev belastet med Newcastle disease-virus, og 95 % af kyllingerne opnåede beskyttelse, sammenholdt med 0-10 % i den uvaccinerede gruppe.
English: Especially tell your doctor:
Danish: Du skal især fortælle det til din læge:
English: Adopted at the 26-29 November 2018 PRAC
Danish: Vedtaget på PRAC's møde den 26.-29. november 2018
English: Fournier´s gangrene has to be treated immediately.
Danish: Fourniers gangræn skal behandles øjeblikkeligt.
English: If you are pregnant, think you may be pregnant or are planning to have a baby, tell your doctor straight away.
Danish: Hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du fortælle det til din læge med det samme.
English: Thiamazole (synonym: methimazole)
Danish: Thiamazol (synonym: methimazol)
English: Your treatment with <medicinal product> may need to be continued during pregnancy if the potential benefit outweighs the potential risk to you and your unborn baby.
Danish: Behandlingen med <lægemiddel> kan muligvis fortsættes under graviditeten, hvis den mulige fordel opvejer den mulige risiko for dig og dit ufødte barn.
English: What you need to know before you take X
Danish: Det skal du vide, før du begynder at tage X
English: If Fournier's gangrene is suspected, X should be discontinued and prompt treatment (including antibiotics and surgical debridement) should be instituted.
Danish: Hvis der er mistanke om Fourniers gangræn, bør X seponeres, og øjeblikkelig behandling (herunder antibiotika og kirurgisk debridement) bør iværksættes.
English: What you need to know before you use Victoza In particular, tell your doctor, pharmacist or nurse if you are using medicines containing any of the following active substances:
Danish: Det skal du vide, før du begynder at bruge Victoza Det er især vigtigt, at du fortæller det til lægen, apotekspersonalet eller sygeplejersken, hvis du bruger medicin, der indeholder et eller flere af følgende aktive stoffer:
English: Frequency ‘not known': Acute pancreatitis
Danish: Hyppighed "ikke kendt": Akut pancreatitis
English: What you need to know before you take <medicinal product> Warnings and precautions <Medicinal product> can cause harm to an unborn baby.
Danish: Det skal du vide, før du begynder at tage <lægemiddel> Advarsler og forsigtighedsregler <Lægemiddel> kan være skadeligt for det ufødte barn.
English: If you could get pregnant, use reliable contraception from the time you start treatment and during treatment.
Danish: Hvis du kan blive gravid, skal du anvende sikker prævention fra det tidspunkt, du starter behandlingen, og under hele behandlingen.
English: Re-exposure may result in recurrence of acute pancreatitis, with decreased time to onset.
Danish: Geneksponering kan medføre recidiv af akut pancreatitis med nedsat tid til debut.
English: Hyperthyroidism in pregnant women should be adequately treated to prevent serious maternal and foetal complications.
Danish: I tilfælde af hyperthyroidisme hos gravide kvinder bør relevant behandling iværksættes for at forebygge alvorlige komplikationer hos moderen og fostret.
English: Carbimazole; thiamazole - New information on the known risk of birth defects and neonatal disorders in case of exposure during pregnancy (EPITT no 19238)
Danish: Carbimazol; thiamazol - nye oplysninger om den kendte risiko for fødselsdefekter og neonatale sygdomme i tilfælde af eksponering under graviditet (EPITT nr. 19238)
English: The dose of immediate-release exenatide does not need to be adjusted on a day-by-day basis depending on self-monitored glycaemia.
Danish: Dosis af exenatid med umiddelbar udløsning behøver ikke at blive justeret dagligt på baggrund af glykæmisk selv-monitorering.
English: The use of prolonged-release exenatide does not require additional self-monitoring.
Danish: Ved anvendelse af depotformulering af exenatid er yderligere selvmonitorering ikke påkrævet.
English: These symptoms could be a sign of a rare but serious or even life-threatening infection, called necrotizing fasciitis of the perineum or Fournier's gangrene which destroys the tissue under the skin.
Danish: Disse symptomer kan være et tegn på en sjælden, men alvorlig og muligvis livstruende infektion (såkaldt nekrotiserende fasciitis i mellemkødet eller Fourniers gangræn), der ødelægger vævet under huden.
English: Be aware that either uro-genital infection or perineal abscess may precede necrotizing fasciitis.
Danish: Vær opmærksom på, at såvel urogenitale infektioner som abscesser i mellemkødet kan optræde før forekomst af nekrotiserende fasciitis.
English: You will not need to test your sugar levels on a day-by-day basis to set the dose of Byetta.
Danish: Du behøver ikke at tjekke dit blodsukkerniveau hver dag for at fastslå Byetta-dosen.
English: Frequency not known (cannot be estimated from available data): Discoloration, numbness and pain in fingers or toes (Raynaud's phenomenon).
Danish: Hyppighed ikke kendt (kan ikke estimeres ud fra forhåndenværende data): Misfarvning, følelsesløshed og smerter i fingre eller tæer (Raynauds syndrom).
English: Thiamazole is able to cross the human placenta.
Danish: Thiamazol kan krydse placentabarrieren.
English: Pregnancy <Medicinal product> can cause harm to an unborn baby.
Danish: Graviditet <Lægemiddel> kan være skadeligt for det ufødte barn.
English: Reported malformations include aplasia cutis congenita, craniofacial malformations (choanal atresia; facial dysmorphism), exomphalos, oesophageal atresia, omphalo-mesenteric duct anomaly, and ventricular septal defect.
Danish: De indberettede misdannelser omfatter aplasia cutis congenita, kraniofaciale misdannelser (choanal atresi, facial dysmorfisme), navlebrok, øsofageal atresi, ductus omphaloentericus-anomali og ventrikelseptumdefekt.
English: Other medicines and Trulicity
Danish: Brug af anden medicin sammen med Trulicity
English: Warnings and precautions …Tell your doctor straight away if you develop fever or abdominal pain, which may be signs of inflammation of the pancreas (acute pancreatitis).
Danish: Advarsler og forsigtighedsregler ... Fortæl det straks til din læge, hvis du oplever feber eller mavesmerter, som kan være tegn på betændelse i bugspytkirtlen (akut pancreatitis).
English: The use of Trulicity does not require blood glucose self-monitoring.
Danish: Brug af Trulicity kræver ikke egenkontrol af blodglucose.
English: <Product name> may need to be discontinued.
Danish: Det kan være nødvendigt at ophøre behandlingen med <lægemiddel>.
English: Other medicines and Bydureon
Danish: Brug af anden medicin sammen med Bydureon
English: Carbimazole is able to cross the human placenta.
Danish: Carbimazol kan krydse placentabarrieren.
English: Necrotising fasciitis of the perineum or Fournier´s gangrene, a serious soft tissue infection of the genitals or the area between the genitals and the anus.
Danish: Nekrotiserende fasciitis i mellemkødet (Fourniers gangræn), en alvorlig bløddelsinfektion i kønsdelene eller området mellem kønsdelene og anus.
English: What you need to know before you use Byetta Warnings and precautions
Danish: Det skal du vide, før du begynder at tage Byetta Advarsler og forsigtighedsregler
English: In case of acute pancreatitis, thiamazole should be discontinued immediately.
Danish: I tilfælde af akut pancreatitis bør thiamazol seponeres øjeblikkeligt.
English: Lichenoid reactions (itchy reddish-purple skin rash and/or threadlike white-grey lines on mucous membranes) with frequency ‘rare'
Danish: Lichenoide reaktioner (kløende, rødligt-lilla hududslæt og/eller trådlignende gråhvide linjer på slimhinderne) med hyppigheden "sjælden"
English: Based on human experience from epidemiological studies and spontaneous reporting, thiamazole is suspected to cause congenital malformations when administered during pregnancy, particularly in the first trimester of pregnancy and at high doses.
Danish: På grundlag af humane data fra epidemiologiske studier og spontane indberetninger formodes thiamazol at forårsage medfødte misdannelser, når det administreres under graviditet, især i første trimester af graviditeten og ved høje doser.
English: However, if you are also using a sulphonylurea or an insulin your doctor may tell you to check your blood sugar levels to adjust the dose of sulphonylurea or insulin.
Danish: Hvis du også anvender et sulfonylurinstof eller et insulinpræparat, kan det være, at lægen vil fortælle dig, at du skal tjekke dit blodsukkerniveau for at tilpasse dosen af sulfonylurinstof eller insulin.
English: The use of carbimazole in pregnant women must be based on the individual benefit/risk assessment.
Danish: Brugen af carbimazol hos gravide kvinder skal baseres på en individuel vurdering af fordele og risici.
English: Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, particularly:
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig, især:
English: Perindopril - Raynaud's phenomenon (EPITT no 19248)
Danish: Perindopril - Raynauds syndrom (EPITT nr. 19248)
English: Based on human experience from epidemiological studies and spontaneous reporting, carbimazole is suspected to cause congenital malformations when administered during pregnancy, particularly in the first trimester of pregnancy and at high doses.
Danish: På grundlag af humane data fra epidemiologiske studier og spontane indberetninger formodes carbimazol at forårsage medfødte misdannelser, når det administreres under graviditet, især i første trimester af graviditeten og ved høje doser.
English: Undesirable effects Tabulated list of adverse reactions Skin and subcutaneous tissue disorders Frequency ‘rare': Lichenoid reactions
Danish: Oversigt over bivirkninger Hud og subkutane væv Hyppighed "sjælden": Lichenoide reaktioner
English: Dulaglutide; exenatide; liraglutide - Diabetic ketoacidosis (EPITT no 19237)
Danish: Dulaglutid; exenatid; liraglutid - diabetisk ketoacidose (EPITT nr. 19237)
English: The use of thiamazole in pregnant women must be based on the individual benefit/risk assessment.
Danish: Brugen af thiamazol hos gravide kvinder skal baseres på en individuel vurdering af fordele og risici.
English: What you need to know before you use Bydureon Warnings and precautions
Danish: Det skal du vide, før du begynder at bruge Bydureon Advarsler og forsigtighedsregler
English: Carbimazole; thiamazole - Pancreatitis (EPITT no 19274)
Danish: Carbimazol; thiamazol - pancreatitis (EPITT nr. 19274)
English: Certolizumab pegol; etanercept; golimumab; infliximabLichenoid skin reactions (EPITT no 19128)
Danish: Certolizumab pegol; etanercept; golimumab; infliximablichenoide hudreaktioner (EPITT nr. 19128)
English: If you are using insulin, your doctor will tell you how to reduce the dose of insulin and will recommend you to monitor your blood sugar more frequently, in order to avoid hyperglycaemia (high blood sugar) and diabetic ketoacidosis (a complication of diabetes that occurs when the body is unable to break down glucose because there is not enough insulin).
Danish: Hvis du anvender insulin, vil din læge fortælle dig, hvordan du skal reducere insulindosen, og vil anbefale dig at overvåge dit blodsukker hyppigere med henblik på at undgå hyperglykæmi (for højt blodsukker) og diabetisk ketoacidose (en komplikation til diabetes, der forekommer, når kroppen ikke er i stand til at nedbryde glukose, fordi der ikke er nok insulin).
English: Necrotising fasciitis of the perineum (Fournier´s Gangrene)1 Frequency: not known
Danish: Infektioner og parasitære sygdomme Nekrotiserende fasciitis i perineum (Fourniers gangræn)1 Hyppighed: "ikke kendt"
English: - if you are using insulin, your doctor will tell you how to reduce the dose of insulin and will recommend you to monitor your blood sugar more frequently, in order to avoid hyperglycaemia (high blood sugar) and diabetic ketoacidosis (a complication of diabetes that occurs when the body is unable to break down glucose because there is not enough insulin).
Danish: - hvis du anvender insulin, vil din læge fortælle dig, hvordan du skal reducere insulindosen, og vil anbefale dig at overvåge dit blodsukkerniveau hyppigere med henblik på at undgå hyperglykæmi (for højt blodsukkerniveau) og diabetisk ketoacidose (en komplikation til diabetes, der forekommer, når kroppen ikke er i stand til at nedbryde glukose, fordi der ikke er nok insulin).
English: In case of acute pancreatitis, carbimazole should be discontinued immediately.
Danish: I tilfælde af akut pancreatitis bør carbimazol seponeres øjeblikkeligt.
English: Not known (frequency cannot be estimated from the available data) …inflammation of the pancreas (acute pancreatitis).
Danish: Ikke kendt (kan ikke estimeres ud fra forhåndenværende data) … betændelse i bugspytkirtlen (akut pancreatitis).
English: Tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicine.
Danish: Fortæl det altid til lægen, apotekspersonalet eller sundhedspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.