FrancophonIA/ELRC3.0 huggingface dataset:
English: No information is available on the safety and efficacy of the concurrent use of this product with vaccines.
Danish: Der foreligger ingen oplysninger om sikkerhed og virkning ved samtidig anvendelse af dette produkt og vacciner.
English: Colony stimulating factors regulate the production and functional activities of immune cells.
Danish: Kolonistimulerende faktorer regulerer dannelsen af immunceller samt deres funktionelle aktiviteter.
English: There may also be other effects including nausea and a skin rash, hypersensitivity reactions (breathing difficulties, hypotension, urticarial and angioedema).
Danish: Der kan også være andre følgevirkninger, inklusive kvalme og hududslæt, overfølsomhedsreaktioner (vejrtrækningsproblemer, hypotension, urticaria og angioødem).
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only.
Danish: TEKSTEN KUN "TIL DYR" Til dyr.
English: People with known hypersensitivity to pegbovigrastim should avoid contact with the veterinary medicinal product.
Danish: Ved kendt overfølsomhed over for pegbovigrastim bør kontakt med veterinærlægemidlet undgås.
English: Evidence from similar active substances in humans suggests that accidental administration of more than the authorised dose could result in adverse reactions, which are related to the activity of pegbovigrastim.
Danish: Data fra lignende aktive stoffer hos mennesker antyder, at utilsigtet administration af mere end den tilladte dosis kan medføre bivirkninger, som er relateret til pegbovigrastims aktivitet.
English: Cattle (dairy cows and heifers).
Danish: Kvæg (malkekøer og kvier).
English: There is no information about the pharmacokinetics of pegbovigrastim in cattle.
Danish: Der foreligger ingen oplysninger om farmakokinetikken af pegbovigrastim hos kvæg.
English: There may also be other effects including nausea and a skin rash, hypersensitivity reactions (breathing difficulties, hypotension, urticaria and angioedema).
Danish: Der kan også være andre følgevirkninger, inklusive kvalme og hududslæt, overfølsomhedsreaktioner (vejrtrækningsproblemer, hypotension, kløe og angioødem).
English: The cows presented with swelling of mucous membranes (notably vulva and eyelid), skin reactions, increased respiration rate and salivation.
Danish: Køerne fik hævede slimhinder (især vulva og øjenlåg), hudreaktioner, øget åndedrætsfrekvens og savlen.
English: Clinical mastitis is investigated as a change in the appearance of the milk or of the quarter or of both milk and quarter.
Danish: Klinisk mastitis undersøges ud fra en forandring i mælkens og yverets udseende.
English: Pegbovigrastim is a modified form of the naturally occurring immunoregulatory cytokine, bovine granulocyte colony stimulating factor (bG-CSF).
Danish: Pegbovigrastim er en modificeret form af det naturligt forekommende immunregulerende cytokin, bovin granulocyt-kolonistimulerende faktor (bG-CSF).
English: There is no information available about the pharmacokinetics of pegbovigrastim in cattle.
Danish: Der foreligger ingen tilgængelige oplysninger om farmakokinetikken af pegbovigrastim hos kvæg.
English: Pegylated bovine granulocyte colony stimulating factor
Danish: Pegyleret bovin granulocytkolonistimulerende faktor
English: Bovine granulocyte colony stimulating factor is a naturally occurring protein produced by mononuclear leukocytes, endothelial cells and fibroblasts.
Danish: Bovin granulocyt-kolonistimulerende faktor er et naturligt forekommende protein, som produceres af mononukleare leukocytter, endotheliale celler og fibroblaster.
English: The content of a second pre-filled syringe is to be injected subcutaneously within 24 hours after calving.
Danish: Indholdet af den anden fyldte sprøjte skal injiceres subkutant inden for 24 timer efter kælvning.
English: Concurrent administration of substances which alter immune function (e.g. corticosteroids or non steroidal anti-inflammatory drugs) may reduce the efficacy of the product.
Danish: Samtidig administration af stoffer, som ændrer immunfunktionen (f.eks. kortikosteroider eller nonsteroide anti-inflammatoriske lægemidler) kan nedsætte veterinærlægemidlets virkning.
English: 50 syringes.
Danish: 50 sprøjter.
English: CONTRAINDICATIONS Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Danish: Bør ikke anvendes i tilfælde af overfølsomhed over for det aktive stof, eller over for et eller flere af hjælpestofferne.
English: Evidence from similar active substances in humans suggests that accidental administration to cattle of more than the authorised dose could result in adverse reactions, which are related to the activity of pegbovigrastim.
Danish: Data fra lignende aktive stoffer hos mennesker antyder, at utilsigtet indgift hos kvæg af mere end den tilladte dosis kan medføre bivirkninger, som er relateret til pegbovigrastims aktivitet.
English: TARGET SPECIES Cattle (dairy cows and heifers)
Danish: DYREARTER Kvæg (malkekøer og kvier)
English: 100 syringes.
Danish: 100 sprøjter.
English: PHARMACEUTICAL FORM Solution for injection Clear, colourless to pale yellow solution
Danish: LÆGEMIDDELFORM Injektionsvæske, opløsning Klar, farveløs til lysegul opløsning
English: Pegbovigrastim (Pegylated bovine Granulocyte Colony Stimulating Factor [PEG bG-CSF]) 15 mg For the full list of excipients, see section 6.1.
Danish: Pegbovigrastim (pegyleret bovin granulocyt-kolonistimulerende faktor [PEG bG-CSF]) 15 mg Alle hjælpestoffer er anført under pkt.
English: Subcutaneous administration.
Danish: Subkutan administration
English: 10 syringes.
Danish: 10 sprøjter.
English: In one safety study in Jersey cows, at overdose of 60 µg/kg, administered on three occasions (1.5x the highest recommended dose), abomasal ulcers were observed.
Danish: I et sikkerhedsstudie hos jerseykøer ved en overdosis på 60 µg/kg administreret ved tre lejligheder (1,5 x den højeste anbefalede dosis) blev der observeret sår i abomasum.
English: In one safety study in Jersey cows the margin of safety of this product was 1.5x the highest recommended dose (an overdose of 60µg/kg was administered on three occasions).
Danish: I et sikkerhedsstudie hos jerseykøer var sikkerhedsmarginen for dette produkt 1,5 x den højeste anbefalede dosis (en overdosis på 60 µg/kg blev administreret ved tre lejligheder).
English: UK-L24 2LN
Danish: L24 2LN Storbritannien
English: In one safety study in Jersey cows the margin of safety of this product was 1.5x the highest recommended dose (an overdose of 60µg/kg was administered on three occasions) (see also section 4.10).
Danish: I et sikkerhedsstudie hos jerseykøer var sikkerhedsmarginen for dette lægemiddel 1,5 x den højeste anbefalede dosis (en overdosis på 60 µg/kg blev administreret ved tre lejligheder) (se også pkt.
English: As expected from the mode of action of the active substance, safety data shows that a mild and transient rise in somatic cell counts in individual cows may be seen.
Danish: Sikkerhedsdata viser, at der kan ses en let og forbigående stigning i somatiske celletal hos individuelle køer, som det kan forventes af det aktive stofs virkningsmekanisme.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Imrestor 15 mg solution for injection for cattle
Danish: VETERINÆRLÆGEMIDLETS NAVN Imrestor 15 mg injektionsvæske, opløsning til kvæg
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Imrestor 15 mg solution for injection for cattle pegbovigrastim
Danish: VETERINÆRLÆGEMIDLETS NAVN Imrestor 15 mg injektionsvæske, opløsning til kvæg pegbovigrastim
English: WITHDRAWAL PERIOD(S) Withdrawal period(s):
Danish: TILBAGEHOLDELSESTID(er) Tilbageholdelsestid:
English: Meat and offal: zero days.
Danish: Slagtning: nul dage.
English: NOT APPLICA BLE
Danish: Ikke relevant
English: NO ENTRY
Danish: Ingen angivelse
English: PACKAGE LEAFLET Imrestor 15 mg solution for injection for cattle
Danish: INDLÆGSSEDDEL: Imrestor 15 mg injektionsvæske, opløsning til kvæg
English: Or
Danish: C.
English: 6.1 List of excipients
Danish: 4.3 Kontraindikationer
English: In the case of accidental self -injection, headache, bone and muscle pain may occur.
Danish: Særlige forholdsregler der skal træffes af personer, der administrerer lægemidlet til dyr: I tilfælde af utilsigtet selvinjektion kan der forekommer hovedpine og knogle- og muskelsmerter.
English: The dose is one inhalation (‘puff') into the mouth once a day at the same time each day.
Danish: Dosis er én inhalation (ét drag) i munden én gang om dagen på samme tidspunkt hver dag.
English: Further information on Revinty Ellipta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Revinty Ellipta findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Revinty Ellipta received a marketing authorisation valid throughout the EU on 2 May 2014.
Danish: Revinty Ellipta fik en markedsføringstilladelse med gyldighed i hele EU den 2. maj 2014.
English: These patients were already well controlled with the comparator medicine and Revinty Ellipta treatment was able to maintain their FEV1.
Danish: Disse patienter var i forvejen velkontrollerede med sammenligningslægemidlet, og behandlingen med Revinty Ellipta var i stand til at opretholde deres FEV1.
English: As for all medicines, data on the use of Revinty Ellipta are continuously monitored.
Danish: Som for alle lægemidler, er data vedrørende brug af Revinty Ellipta løbende overvåget.
English: The company that makes Relvar Ellipta has agreed that its scientific data can be used for Revinty Ellipta (‘informed consent').
Danish: Virksomheden, som fremstiller Revinty Ellipta, har indvilget i, at dens videnskabelige oplysninger må anvendes for Revinty Ellipta ("informeret samtykke").
English: It works on various types of immune cells, blocking the release of substances involved in inflammation.
Danish: Det virker på forskellige typer immunceller ved at blokere frigivelsen af stoffer, der medvirker til betændelse (inflammation).
English: For more information about using Revinty Ellipta, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Revinty Ellipta, se indlægssedlen, eller kontakt lægen eller apotekspersonalet.
English: Side effects reported with Revinty Ellipta are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger indberettet for Revinty Ellipta vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
English: It attaches to beta-2 receptors in the airways and causes the muscles of the airways to relax and widen, allowing the patient to breathe more easily.
Danish: Det bindes til beta-2 receptorer i luftvejene, så musklerne i luftvejene slapper af og udvider sig, så patienten får lettere ved at trække vejret.
English: What measures are being taken to ensure the safe and effective use of Revinty Ellipta?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Revinty Ellipta?
English: The European Medicines Agency concluded that Revinty Ellipta'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 Revinty Ellipta opvejer risiciene, og det kan godkendes til anvendelse i EU.
English: Revinty Ellipta (fluticasone furoate / vilanterol)
Danish: Revinty Ellipta (fluticasonfuroat/vilanterol)
English: The most common side effects with Revinty Ellipta (which may affect more than 1 in 10 people) are headache and nasopharyngitis (inflammation of the nose and throat).
Danish: De hyppigste bivirkninger ved Revinty Ellipta (som kan forekomme hos mere end 1 ud af 10 personer) er hovedpine og betændelse i næse og svælg (nasofaryngitis).
English: An overview of Revinty Ellipta and why it is authorised in the EU
Danish: En oversigt over Revinty Ellipta og hvorfor det er godkendt i EU
English: Relvar Ellipta is available as an inhaler in two strengths (92/22 micrograms and 184/22 micrograms).
Danish: Revinty Ellipta fås som en inhalator i to styrker (92/22 µg og 184/22 µg).
English: Other information about Revinty Ellipta
Danish: Andre oplysninger om Revinty Ellipta
English: More serious side effects include pneumonia and fractures (seen in up to 1 in 10 people), which were reported more often in patients with COPD than those with asthma.
Danish: Mere alvorlige bivirkninger er lungebetændelse og knoglebrud (optræder hos op til 1 ud af 10 personer), som oftere indberettes for patienter med KOL end for patienter med astma.
English: Revinty Ellipta can only be obtained with a prescription.
Danish: Revinty Ellipta udleveres kun efter recept.
English: This medicine is the same as Relvar Ellipta, which is already authorised in the EU.
Danish: Lægemidlet er identisk med Revinty Ellipta, som allerede er godkendt i EU.
English: In two further studies, Revinty Ellipta reduced the number of flare-ups by between 13 and 34% more than vilanterol alone
Danish: I to yderligere studier reducerede Revinty Ellipta antallet af episoder med forværring med mellem 13 og 34 % mere end vilanterol alene
English: Regarding its safety, the most frequent side effects reported with Revinty Ellipta were similar to those seen with other COPD and asthma treatments; an increased incidence of pneumonia was observed in patients with COPD.
Danish: Med hensyn til sikkerheden svarer de hyppigste bivirkninger, der er rapporteret med Revinty Ellipta, til dem, der ses med andre KOL- og astmamidler; hos KOL-patienter iagttoges øget forekomst af lungebetændelse.
English: A fourth study in 1,522 patients showed that Revinty Ellipta was as effective as another medicine containing a corticosteroid (fluticasone propionate) and a long-acting beta-2 agonist (salmeterol).
Danish: Et fjerde studie hos 1 522 patienter viste, at Revinty Ellipta var lige så effektivt som et andet lægemiddel, der indeholdt et binyrebarkhormon (fluticasonpropionat) og et langtidsvirkende beta-2stimulerende middel (salmeterol).
English: In a third study, fewer patients taking Revinty Ellipta 92/22 had at least one severe flare-up after a year of treatment than those taking fluticasone furoate alone (13% versus 16%).
Danish: I et tredje studie havde færre patienter, der fik Revinty Ellipta 92/22, mindst én svær episode med forværring efter et års behandling, end de, der fik fluticasonfuroat alene (13 % mod 16 %).
English: What is Revinty Ellipta and what is it used for?
Danish: Hvad er Revinty Ellipta, og hvad anvendes det til?
English: Revinty Ellipta 184/22 also improved FEV1 by 193 ml more than fluticasone furoate and 210 ml more than another inhaler containing fluticasone propionate.
Danish: Revinty Ellipta 184/22 forbedrede desuden FEV1 med 193 ml mere end fluticasonfuroat og 210 ml mere end en anden inhalator indeholdende fluticasonpropionat.
English: Why is Revinty Ellipta authorised in the EU?
Danish: Hvorfor er Revinty Ellipta godkendt i EU?
English: Revinty Ellipta contains the active substances fluticasone furoate and vilanterol.
Danish: Revinty Ellipta indeholder de aktive stoffer fluticasonfuroat og vilanterol.
English: The first study showed that Revinty Ellipta 92/22 improved average FEV1 by 115 ml more than placebo, and a second study showed that Revinty Ellipta 184/22 improved average FEV1 by 131 ml more than placebo.
Danish: Det første studie viste, at Revinty Ellipta 92/22 forbedrede det gennemsnitlige FEV1 med 115 ml mere end placebo, mens det andet studie viste, at Revinty Ellipta 184/22 forbedrede det gennemsnitlige FEV1 med 131 ml mere end placebo.
English: Revinty Ellipta is an inhaler for treating asthma and chronic obstructive pulmonary disease (COPD).
Danish: Revinty Ellipta er et inhalationslægemiddel til behandling af astma og kronisk obstruktiv lungesygdom (KOL).
English: What are the risks associated with Revinty Ellipta?
Danish: Hvilke risici er der forbundet med Revinty Ellipta?
English: • whose symptoms are not controlled with an inhaled corticosteroid and an inhaled short-acting
Danish: • hos hvem symptomerne ikke er kontrolleret med et inhaleret binyrebarkhormon og et inhaleret korttidsvirkende beta-2-stimulerende middel
English: Revinty Ellipta contains two active substances that work in different ways to improve breathing in patients with asthma and COPD.
Danish: Revinty Ellipta indeholder to aktive stoffer, der på hver sin måde forbedrer vejrtrækningen hos patienter med astma og KOL.
English: For the full list of side effects of Revinty Ellipta, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger af Revinty Ellipta fremgår af indlægssedlen.
English: Three studies in over 3,200 patients showed that Revinty Ellipta improves breathing and reduces flareups in patients with persistent asthma.
Danish: Tre studier hos over 3 200 patienter har vist, at Revinty Ellipta forbedrer vejrtrækningen og reducerer episoder med forværring hos patienter med vedholdende astma.
English: In two of the studies, Revinty Ellipta 92/22 increased the volume of air a patient could breathe out in one second (FEV1) by 36 ml more than fluticasone furoate alone and 172 ml more than placebo (a dummy treatment).
Danish: I to af studierne øgede Revinty Ellipta 92/22 den mængde luft, en patient kunnet udånde på ét sekund (FEV1), med 36 ml mere end fluticasonfuroat alene og 172 ml mere end virkningsløs behandling (placebo).
English: • whose symptoms are adequately controlled with both inhaled corticosteroids and a long-acting
Danish: • hos hvem symptomerne er tilstrækkeligt kontrolleret med inhalation af både binyrebarkhormon og et langtidsvirkende beta-2-stimulerende middel
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Revinty Ellipta have also 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 Revinty Ellipta.
English: Four studies in over 5,500 patients showed that Revinty Ellipta improves breathing and reduces flare ups of symptoms in patients with COPD.
Danish: Fire studier med over 5 500 patienter har vist, at Revinty Ellipta forbedrer vejrtrækningen og reducerer episoder med forværring af symptomer hos patienter med KOL.
English: Revinty Ellipta improves breathing and reduces flare ups of symptoms in patients with asthma and COPD.
Danish: Revinty Ellipta giver bedre vejrtrækning og færre episoder med forværring af symptomerne hos patienter med astma og KOL.
English: How is Revinty Ellipta used?
Danish: Hvordan anvendes Revinty Ellipta?
English: What benefits of Revinty Ellipta have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Revinty Ellipta?
English: How does Revinty Ellipta work?
Danish: Hvordan virker Revinty Ellipta?
English: It is given twice a day.
Danish: Det indgives to gange dagligt.
English: Without ergosterol, the fungus cannot spread or dies.
Danish: Uden ergosterol kan svampen ikke brede sig, eller den dør.
English: The dose may be increased or decreased according to how the patient responds.
Danish: Dosen kan øges eller sættes ned, afhængigt af hvordan patienten reagerer.
English: The full EPAR and risk management plan summary for Voriconazole Hikma can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Voriconazole Hikma findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Patients need to receive an initial higher dose (loading dose) on the first day.
Danish: Den første dag skal patienterne have en højere startdosis (en støddosis).
English: Therefore, the CHMP's view was that, as for Vfend, the benefit outweighs the identified risk.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Vfend.
English: As for every medicine, the company provided studies on the quality of voriconazole.
Danish: Som for alle lægemidler fremlagde virksomheden undersøgelser af kvaliteten af voriconazol.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Voriconazole Hikma on 27 May 2015.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Voriconazole Hikma den 27. maj 2015.
English: It works by disrupting the formation of ergosterol, which is an important part of fungal cell membranes.
Danish: Det virker ved at stoppe dannelsen af ergosterol, som er en vigtig del af svampecellemembranerne.
English: The aim of the loading dose is to attain effective blood levels quickly.
Danish: Formålet med støddosen er hurtigt at opnå et stabilt indhold i blodet.
English: This is a summary of the European public assessment report (EPAR) for Voriconazole Hikma.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Voriconazole Hikma.
English: There was no need for ‘bioequivalence' studies to investigate whether voriconazole is absorbed similarly to the reference medicine, Vfend, to produce the same level of the active substance in the blood.
Danish: Der krævedes ingen bioækvivalensundersøgelser for at se nærmere på, om voriconazol absorberes på samme måde som referencelægemidlet, Vfend, for at kunne danne den samme mængde af det aktive stof i blodet.
English: The loading dose is then followed by a maintenance dose that can be adjusted according to the patient's response.
Danish: Støddosen efterfølges af en vedligeholdelsesdosis, der kan tilpasses efter, hvordan patienten reagerer på behandlingen.
English: • invasive aspergillosis (a type of fungal infection due to Aspergillus);
Danish: • invasiv aspergillose (en svampeinfektion forårsaget af Aspergillus)
English: Both the loading and the maintenance doses are given by infusion, but once patients improve prescribers should consider switching patients to a voriconazole medicine that can be given by mouth.
Danish: Både støddosis og vedligeholdelsesdosis gives ved infusion, men når patientens tilstand bliver bedre, bør lægen lade patienten skifte til et lægemiddel med voriconazol taget gennem munden.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Voriconazole Hikma has been shown to be comparable to Vfend.
Danish: Udvalget for Lægemidler til Mennesker (CHMP) konkluderede, at det i overensstemmelse med EU's krav er påvist, at Voriconazole Hikma er sammenligneligt med Vfend.
English: • candidaemia (a type of fungal infection due to Candida) in patients with a normal white blood cell count;
Danish: • candidæmi (en svampeinfektion forårsaget af Candida) hos patienter med normalt antal hvide blodlegemer,
English: The dose of Voriconazole Hikma depends on the weight of the patient.
Danish: Doseringen af Voriconazole Hikma afhænger af patientens vægt.
English: This is because voriconazole is given by infusion into a vein, so the active substance is delivered straight into the bloodstream.
Danish: Dette skyldes, at voriconazol gives ved infusion i en vene, så det aktive stof ledes direkte ind i blodbanen.
English: Voriconazole Hikma is also used to prevent fungal infections in patients who have had haematopoietic (blood) stem-cell transplantation (a transplant of a type of stem cells that can develop into blood cells) and are at high risk of infection.
Danish: Voriconazole Hikma anvendes desuden til forebyggelse af svampeinfektioner hos patienter, der har fået foretaget en hæmatopoietisk (blod)stamcelletransplantation (transplantation af en type stamceller, der kan udvikle sig til blodlegemer), og som har høj risiko for infektion.
English: A risk management plan has been developed to ensure that Voriconazole Hikma is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Voriconazole Hikma anvendes så sikkert som muligt.