FrancophonIA/ELRC3.0 huggingface dataset:
English: Disposal: read package leaflet supplied with the lyophilisate vial.
Danish: Bortskaffelse: læs indlægssedlen, der blev leveret med hætteglasset med lyofilisat.
English: la Selva, 135 Amer, 17170 Girona Spain
Danish: la Selva, 135 Amer, 17170 Girona Spanien
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard boxes (solvent bags)
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Kartonæsker (poser med solvens)
English: After the administration of a 10-fold overdose, a mild exudate and slight congestion in the bursa of Fabricius were very commonly observed.
Danish: Efter indgivelse af en 10-dobbelt overdosis blev der meget ofte observeret let ekssudat og en let tilstopning af Bursa fabricii.
English: Each dose (0.05 ml for in ovo or 0.2 ml for SC) contains: Live attenuated IBDV, strain 1052…………….. 101.48 - 102.63 PU* * PU: Potency Units
Danish: Hver dosis (0,05 ml for in ovo eller 0,2 ml for subkutant) indeholder: Levende, svækket IBDV, stamme 1052…….. 101,48-102,63 PU* * PU: Potensenheder
English: For the reconstitution and administration of the vaccine, use sterile equipment free from any residues of chemical disinfectants.
Danish: Anvend sterilt udstyr uden rester af kemiske desinfektionsmidler til rekonstitution og indgivelse af vaccinen.
English: By the subcutaneous route: Administer one single injection of 0.2 ml of the reconstituted vaccine to each chick at 1 day of age.
Danish: Ved subkutan injektionsvej: Indgiv en enkelt dosis på 0,2 ml af den rekonstituerede vaccine pr. kylling til daggamle kyllinger.
English: la Selva, 135 Amer, 17170 (Girona) Spain
Danish: la Selva, 135 Amer, 17170 (Girona) Spanien
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Solvent bag
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE Pose med solvens
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard boxes (lyophilisate vials)
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Kartonæsker (hætteglas med lyofilisat)
English: Wash and disinfect hands and equipment after use.
Danish: Særlige forsigtighedsregler for personer, som indgiver lægemidlet til dyr Vask og desinficer hænder og udstyr efter brug.
English: Tηλ: +30 210 4978660
Danish: HIPRA EΛΛAΣ A.E. Tηλ: +30 210 4978660
English: GUMBOHATCH lyophilisate for suspension for injection for chickens
Danish: GUMBOHATCH lyofilisat til injektionsvæske, suspension, til kyllinger
English: Solvent for suspension for injection.
Danish: Solvens til injektionsvæske, suspension.
English: PACKAGE LEAFLET: GUMBOHATCH lyophilisate and solvent for suspension for injection for chickens
Danish: INDLÆGSSEDDEL: GUMBOHATCH lyofilisat og solvens til injektionsvæske, suspension, til kyllinger
English: Dilutions for subcutaneous administration (0.2 ml per dose): Number and content of vaccine vials:
Danish: Fortyndinger til subkutan administration (0,2 ml pr. dosis): Antal og indhold af vaccinehætteglas:
English: By the in ovo route: Administer one single injection of 0.05 ml of the reconstituted vaccine into each chicken egg at 18 days of embryonation.
Danish: Ved in ovo injektionsvej: Indgiv en enkelt dosis på 0,05 ml af den rekonstituerede vaccine i hvert18 dage gammelt embryoner hønseæg.
English: Lyophilisate for suspension for injection.
Danish: Lyofilisat til injektionsvæske, suspension.
English: PU
Danish: B.
English: In ovo or SC use.
Danish: In ovo og subkutan anvendelse.
English: GUMBOHATCH lyophilisate and solvent for suspension for injection for chickens
Danish: GUMBOHATCH lyofilisat og solvens til injektionsvæske, suspension, til kyllinger
English: Dilutions for in ovo administration (0.05 ml per dose): Number and content of vaccine vials:
Danish: Fortyndinger til administration in ovo (0,05 ml pr. dosis): Antal og indhold af vaccinehætteglas
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Lyophilisate vial
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Hætteglas med lyofilisat
English: Live attenuated infectious bursal disease virus (IBDV), strain 1052……….. 101.48 - 102.63 PU* * PU: Potency Units
Danish: Levende, svækket Infectious Bursal Disease Virus (infektiøs bursitis-virus) (IBDV), stamme 1052…………….. 101,48-102,63 PU* * PU: Potensenheder
English: Cardboard box with 10 bags containing 1,000 ml solvent.
Danish: Kartonæske med 10 poser á 1.000 ml solvens.
English: Cardboard box with 10 lyophilisate vials containing 2,500 doses.
Danish: Kartonæske med 10 hætteglas med lyofilisat á 2.500 doser.
English: Cardboard box with 10 bags containing 800 ml solvent.
Danish: Kartonæske med 10 poser á 800 ml solvens.
English: Cardboard box with 10 bags containing 200 ml solvent.
Danish: Kartonæske med 10 poser á 200 ml solvens.
English: Excipients:
Danish: Dosering:
English: 10 x 200 ml 10 x 400 ml 10 x 800 ml 10 x1,000 ml
Danish: 10 x 800 ml.
English: Cardboard box with 10 bags containing 400 ml solvent.
Danish: Kartonæske med 10 poser á 400 ml solvens.
English: Dilutions for subcutaneous administration (0.2 ml per dose) Number and content of vaccine vials:
Danish: Fortyndinger til subkutan administration (0,2 ml pr. dosis):
English: Cardboard box with 10 lyophilisate vials containing 5,000 doses.
Danish: Kartonæske med 10 hætteglas med lyofilisat á 5.000 doser.
English: Cardboard box with 10 lyophilisate vials containing 1,000 doses.
Danish: Kartonæske med 10 hætteglas med lyofilisat á 1.000 doser.
English: Cardboard box with 10 lyophilisate vials containing 2,000 doses.
Danish: Kartonæske med 10 hætteglas med lyofilisat á 2.000 doser.
English: Cardboard box with 10 lyophilisate vials containing 4,000 doses.
Danish: Kartonæske med 10 hætteglas med lyofilisat á 4.000 doser.
English: 10 x 1,000 doses 10 x 2,000 doses 10 x 2,500 doses 10 x 4,000 doses 10 x 5,000 doses
Danish: 10 x 5.000 doser.
English: Live attenuated infectious bursal disease virus (IBDV), strain 1052 …….. 101.48 - 102.63 PU* * PU: Potency Units
Danish: Levende, svækket Infectious Bursal Disease Virus (infektiøs bursitis-virus) (IBDV), stamme 1052…….. 101,48-102,63 PU*
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Danish: Særlige forholdsregler der skal træffes af personer, der administrerer lægemidlet til dyr: Vask og desinficer hænder og udstyr efter brug.
English: EU/1/15/1056/001 Praxbind
Danish: EU/1/15/1056/001 Praxbind 2,5 g/50 ml
English: EU Number
Danish: (EU)-nummer
English: Solution for injection/infusion
Danish: Injektions-/ infusionsvæske, opløsning
English: 50 ml
Danish: Hætteglas 50 ml
English: The European Commission granted a marketing authorisation valid throughout the European Union for Eviplera on 28 November 2011.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Eviplera den 28. november 2011.
English: The full EPAR for Eviplera can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Eviplera 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 Eviplera.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Eviplera.
English: All three active substances are already available in separate medicines in the EU.
Danish: Alle tre aktive stoffer markedsføres i forvejen som separate lægemidler i EU.
English: The recommended dose is one tablet once a day and it must be taken with food.
Danish: Den anbefalede dosis er én tablet én gang dagligt, der tages sammen med et måltid.
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 Eviplera.
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, hvordan Eviplera skal anvendes.
English: The company also presented studies showing that the tablet containing all three substances is absorbed in the body in the same way as the separate tablets given concurrently under similar conditions.
Danish: Virksomheden fremlagde desuden undersøgelser, der viste, at tabletter, der indeholder alle tre stoffer, optages i kroppen på samme måde som de separate tabletter indgivet samtidigt under tilsvarende forhold.
English: Other information about Eviplera
Danish: Andre oplysninger om Eviplera
English: What measures are being taken to ensure the safe and effective use of Eviplera?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Eviplera?
English: For more information about treatment with Eviplera, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Eviplera, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: It also causes fewer side effects in the early stages of treatment and offers the benefit of being taken as one tablet once per day.
Danish: Det har desuden færre bivirkninger i de tidlige stadier af behandlingen og har den fordel, at patienten kun behøver tage én tablet én gang dagligt.
English: Patients who have HIV and hepatitis B may see a worsening of their liver problems when stopping Eviplera.
Danish: Hos patienter, der har hiv og hepatitis B, kan leverproblemerne forværres ved ophør af behandlingen med Eviplera.
English: Eviplera does not cure HIV-1 infection or AIDS, but it may slow the damage to the immune system and the development of infections and diseases associated with AIDS.
Danish: Eviplera helbreder ikke hiv-1-infektion eller aids, men kan sinke den skade på immunsystemet og udviklingen af de infektioner og sygdomme, der er forbundet med aids.
English: Patients who attained a viral load of less than 50 HIV-1 RNA copies/ml after 48 weeks of treatment were considered to have responded to treatment.
Danish: Hos patienter, der opnåede et virusindhold på mindre end 50 hiv-1 RNA-kopier/ml efter 48 ugers behandling, ansås behandlingen for at have virket.
English: Treatment with Eviplera should be started by a doctor who has experience in the management of HIV infection.
Danish: Behandling med Eviplera bør indledes af en læge med erfaring i behandling af hiv-infektion.
English: If Eviplera is given together with rifabutin, the doctor should prescribe an additional 25 mg of rilpivirine per day during rifabutin treatment.
Danish: Hvis Eviplera gives i kombination med rifabutin, bør lægen ordinere yderligere 25 mg rilpivirin pr. dag under behandlingen med rifabutin.
English: Eviplera must not be used with the following medicines as they may lead to reduced blood levels of rilpivirine, and thereby reduce the effectiveness of Eviplera:
Danish: Eviplera må ikke anvendes sammen med følgende lægemidler, da dette kan mindske blodets indhold af rilpivirin og dermed reducere virkningen af Eviplera:
English: Tenofovir is a nucleotide reverse transcriptase inhibitor.
Danish: Tenofovir er en nukleotid-revers transcriptasehæmmer.
English: Eviplera emtricitabine / rilpivirine / tenofovir disoproxil
Danish: Eviplera emtricitabin/rilpivirin/tenofovirdisoproxil
English: Eviplera is a medicine that contains the active substances emtricitabine (200 mg), rilpivirine (25 mg) and tenofovir disoproxil (245 mg).
Danish: Eviplera er et lægemiddel, der indeholder de aktive stoffer emtricitabin (200 mg), rilpivirin (25 mg) og tenofovirdisoproxil (245 mg).
English: Eviplera has also been evaluated in 532 patients who were switched from their current HIV treatment to Eviplera.
Danish: Eviplera blev også undersøgt hos 532 patienter, som skiftede fra den nuværende hiv-behandling til Eviplera.
English: Eviplera has been studied in two main studies in patients with HIV-1 who had not received HIV treatment before.
Danish: Eviplera blev undersøgt i to hovedundersøgelser hos patienter med hiv-1, som ikke tidligere havde fået hiv-behandling.
English: What is the risk associated with Eviplera?
Danish: Hvilken risiko er der forbundet med Eviplera?
English: Rarely, kidney problems may occur in patients taking tenofovir disoproxil.
Danish: Nyreproblemer kan i sjældne tilfælde forekomme hos patienter, der får tenofovirdisoproxil.
English: The two studies evaluating the effects of switching patients to Eviplera showed that Eviplera was as effective as the previous treatment and maintained the reduction in viral load.
Danish: De to undersøgelser, der fokuserede på virkningen af at skifte over til Eviplera, viste, at Eviplera var lige så effektivt som den tidligere behandling og holdt virusindholdet nede.
English: Therefore, the CHMP considered that the benefits of Eviplera outweigh its risks in patients with a low HIV-1 viral load, and recommended that it be granted marketing authorisation for this group of patients.
Danish: CHMP var derfor af den opfattelse, at fordelene ved Eviplera opvejer risiciene hos patienter med lavt indhold af hiv-1, og anbefalede udstedelse af markedsføringstilladelse for denne gruppe af patienter.
English: By blocking this enzyme, Eviplera reduces the amount of HIV-1 in the blood and keeps it at a low level.
Danish: Ved at blokere dette enzym mindsker Eviplera hiv-1mængden i blodet og holder den nede.
English: All three active substances block the activity of reverse transcriptase, a viral enzyme that allows HIV-1 to replicate in the cells it has infected.
Danish: De tre aktivstoffer virker ved at blokere virussets enzym, revers transkriptase, der gør det muligt for hiv-1 at formere sig i de celler, det har smittet.
English: The CHMP concluded that Eviplera was as effective as combinations containing efavirenz.
Danish: CHMP konkluderede, at Eviplera var lige så effektivt som kombinationer indeholdende efavirenz.
English: If patients need to stop taking one of the active substances or if they need to modify their dose, patients should be switched to separate medicines containing emtricitabine, rilpivirine or tenofovir disoproxil.
Danish: Skal patienten holde op med at tage et af de aktive stoffer eller have ændret dosis, skal denne skifte til separate lægemidler, der indeholder emtricitabin, rilpivirin eller tenofovirdisoproxil.
English: However, the CHMP noted that there was some risk of HIV-1 developing resistance to rilpivirine and that this risk appeared to be lower in patients with a lower viral load.
Danish: CHMP bemærkede dog, at der er en vis risiko for, at hiv-1 udvikler resistens over for rilpivirin, og at denne risiko ser ud til at være mindre hos patienter med mindre virusindhold i blodet.
English: For the full list of side effects and restrictions with Eviplera, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Eviplera fremgår af indlægssedlen.
English: It is only used in patients where the virus has not developed resistance to certain anti-HIV medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs), tenofovir or emtricitabine, and who have HIV levels in the blood (viral load) of no more than 100,000 HIV-1 RNA copies/ml.
Danish: Det anvendes kun til patienter, hvis virus ikke har udviklet resistens over for visse hiv-lægemidler kaldet non-nukleoside reverse transkriptasehæmmere (NNRTI), tenofovir eller emtricitabin, og hvis indhold af hiv i blodet højst er 100 000 hiv-1 RNA-kopier/ml.
English: Patient's previous treatment consisted either of two nucleotide reverse transcriptase inhibitors and another HIV medicine called a boosted protease inhibitor, or the medicine Atripla.
Danish: Patienternes tidligere behandling bestod enten af to nukleotide reverse transkriptasehæmmere og et andet hiv-lægemiddel kaldet en forstærket proteasehæmmer, eller lægemidlet Atripla.
English: Why has Eviplera been approved?
Danish: Hvorfor blev Eviplera godkendt?
English: Eviplera contains three active substances: emtricitabine, which is a nucleoside reverse transcriptase inhibitor; rilpivirine, which is a non-nucleoside reverse transcriptase inhibitor (NNRTI); and tenofovir disoproxil, which is a ‘prodrug' of tenofovir, meaning that it is converted into the active substance tenofovir in the body.
Danish: Eviplera indeholder tre aktive stoffer: emtricitabin, som er en nukleosid-revers transcriptasehæmmer, rilpivirin, som er en non-nukleosid-revers transcriptasehæmmer (NNRTI) og tenofovirdisoproxil, som er et forstadium til tenofovir, dvs. det omdannes til det aktive stof tenofovir i kroppen.
English: In the second study, 87% of the patients in the rilpivirine group (which included patients taking the Eviplera combination) responded to treatment.
Danish: I den anden undersøgelse virkede behandlingen på 87 % af patienterne i rilpivirin-gruppen (som omfattede de patienter, der fik Eviplera-kombinationen).
English: In patients who had received previous HIV treatment, the most common side effects (seen in more than 2 patients in 100) were tiredness, diarrhoea, nausea and insomnia.
Danish: Hos patienter, der tidligere havde fået hiv-behandling, var de hyppigste bivirkninger (som optrådte hos mere end 2 ud af 100 patienter) træthed, diarré, kvalme og søvnløshed.
English: The second main study involving 678 patients compared rilpivirine with efavirenz, both being taken with emtricitabine and tenofovir disoproxil or two other nucleotide reverse transcriptase inhibitors.
Danish: I den anden hovedundersøgelse med 678 patienter blev rilpivirin sammenlignet med efavirenz, der begge blev anvendt i kombination med emtricitabin og tenofovirdisoproxil eller to andre nukleotid-reverse transcriptasehæmmere.
English: In the first main study involving 690 patients, Eviplera was compared with a similar combination that had efavirenz in place of rilpivirine.
Danish: I den første hovedundersøgelse, der omfattede 690 patienter, blev Eviplera sammenlignet med en tilsvarende kombination, der indeholdt efavirenz i stedet for rilpivirin.
English: The most common side effects with Eviplera in patients who had not received previous HIV treatment (seen in more than 5 patients in 100) were nausea (feeling sick), dizziness, abnormal dreams, headache, diarrhoea and insomnia.
Danish: De hyppigste bivirkninger ved Eviplera hos ikke tidligere hiv-behandlede patienter (som optrådte hos mere end 5 ud af 100 patienter) var kvalme, svimmelhed, unormale drømme, hovedpine, diarré og søvnløshed.
English: The Eviplera combination compared well with combinations containing efavirenz.
Danish: Eviplera-kombinationen stod godt mål med kombinationer, der indeholdt efavirenz.
English: In the first study in previously untreated patients, 83% of the patients taking the Eviplera combination responded to treatment compared with 84% of the patients taking a combination with efavirenz.
Danish: I den første undersøgelse hos ikke tidligere behandlede patienter havde behandlingen med Eviplera-kombinationen god virkning hos 83 % af patienterne; den tilsvarende andel var 84 % af de patienter, der fik kombinationen med efavirenz.
English: What is Eviplera?
Danish: Hvad er Eviplera?
English: • systemic dexamethasone (a steroid anti-inflammatory and immunosuppressant medicine) except when used as a single dose treatment;
Danish: • systemisk dexamethason (et steroidt antiinflammatorisk og immunundertrykkende lægemiddel),
English: Eviplera is used to treat adults infected with human immunodeficiency virus-1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Danish: Eviplera anvendes til behandling af voksne, som er inficeret med hiv-1 (humant immundefektvirus type 1).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Eviplera have been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Eviplera.
English: This compared with 83% of patients in the efavirenz group.
Danish: I efavirenz-gruppen var det tilsvarende tal 83 % af patienterne.
English: What benefit has Eviplera shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Eviplera?
English: • St John's wort (a herbal medicine to treat depression and anxiety).
Danish: • prikbladet perikum (naturlægemiddel mod depression og ængstelse).
English: What is Eviplera used for?
Danish: Hvad anvendes Eviplera til?
English: The main measure of effectiveness was based on the reduction in viral load.
Danish: Behandlingens virkning blev hovedsagelig bedømt på faldet i virusindholdet.
English: How has Eviplera been studied?
Danish: Hvordan blev Eviplera undersøgt?
English: How is Eviplera used?
Danish: Hvordan anvendes Eviplera?
English: Respect normal aseptic conditions.
Danish: Normale aseptiske forhold skal overholdes.
English: Onset of immunity: not established.
Danish: Indtræden af immunitet: ikke fastslået.
English: Not all pack sizes may be marketed.
Danish: Alle pakningsstørrelser markedsføres ikke nødvendigvis.
English: Date of last renewal: 31/07/2015
Danish: Dato for seneste fornyelse: 31/07/2015
English: b) the disease to which the product is intended to confer immunity is largely absent from the territory in question.
Danish: b) Sygdommen som produktet ønskes at udvikle immunitet imod i det store hele ikke er tilstede i det pågældende territorium.
English: Since stress could contribute to this adverse reaction, appropriate precautions should be taken to reduce stress as much as possible during the administration of the product.
Danish: Eftersom stress kan bidrage til denne bivirkning, bør der ved administration af produktet tages passende forholdsregler for at begrænse stress-påvirkningen mest muligt.
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Danish: Det aktive indholdsstof som er af biologisk oprindelse med det formål at producere aktiv immunitet, er ikke inkluderet i Forordning (EF) 470/2009.
English: 4.8 Interaction with other medicinal products and other forms of interaction
Danish: 4.8 Interaktioner med andre lægemidler og andre former for interaktion
English: Interaction with other medicinal products and other forms of interaction:
Danish: Interaktioner med andre lægemidler og andre former for interaktion:
English: a) the administration of the product to animals will interfere with the implementation of a national programme for the diagnosis, control or eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
Danish: a) Brug af produktet i dyr vil interferere med indførelsen af et nationalt program til diagnosticering, kontrol eller udryddelse af dyresygdomme, eller det vil forårsage besværligheder med at certificere fravær af kontamination i levende dyr eller i fødevarer eller andre produkter som stammer fra behandlede dyr.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label after {EXP}.
Danish: Dette veterinære lægemiddel må ikke anvendes efter udløbsdatoen anført på flaskens etiket efter {EXP}.
English: The biological significance of the levels of reduction shown in shedding in cattle and goats is not known.
Danish: Den biologiske betydning af niveauet for reduktion i udskillelse i kvæg og geder er ikke kendt.