FrancophonIA/ELRC3.0 huggingface dataset:
English: The Committee recommended that Desloratadine Teva be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Desloratadine Teva.
English: Other information about Desloratadine Teva
Danish: Andre oplysninger om Desloratadine Teva:
English: Why has Desloratadine Teva been approved?
Danish: Hvorfor blev Desloratadine Teva godkendt?
English: What is Desloratadine Teva?
Danish: Hvad er Desloratadine Teva?
English: How has Desloratadine Teva been studied?
Danish: Hvordan blev Desloratadine Teva undersøgt?
English: How is Desloratadine Teva used?
Danish: Hvordan anvendes Desloratadine Teva?
English: What is Desloratadine Teva used for?
Danish: Hvad anvendes Desloratadine Teva til?
English: How does Desloratadine Teva work?
Danish: Hvordan virker Desloratadine Teva?
English: 1 bottle Zero days equivalent to titre prior to inactivation (log10)
Danish: Æske med type I glasflaske med butylelastomer prop svarende til titer før inaktivering (log10)
English: Strength Pharmaceutical Form
Danish: Lægemiddelform Dyrearter, som
English: Route of administration
Danish: Indgivelses vej
English: This summary was last updated in 04-2013.
Danish: Dette sammendrag blev sidst ajourført i 04-2013
English: The vaccine was also generally well tolerated and shown to be safe.
Danish: Vaccinen blev desuden generelt godt tålt og blev påvist at være sikker.
English: Cattle may have a slightly raised body temperature following vaccination.
Danish: Kvægets kropstemperatur kan være en smule forhøjet efter vaccinationen.
English: The vaccine is given to young animals as two injections into the muscle.
Danish: Vaccinen gives til unge dyr som to injektioner i en muskel.
English: Zulvac 1 Bovis was initially authorised under ‘exceptional circumstances'.
Danish: Zulvac 1 Bovis blev oprindeligt godkendt under "særlige omstændigheder".
English: The European Medicines Agency (EMA) reviewed additional information submitted according to an agreed timetable on the quality and safety of the vaccine.
Danish: Det Europæiske Lægemiddelagentur (EMA) gennemgik de i henhold til en aftalt tidsplan fremsendte supplerende oplysninger om vaccinens kvalitet og sikkerhed.
English: The withdrawal period for Zulvac 1 Bovis for meat and milk is zero days.
Danish: Tilbageholdelsestiden for Zulvac 1 Bovis for kød og mælk er nul dage.
English: Protection starts two weeks after the last injection and lasts for a year.
Danish: Beskyttelsen virker to uger efter den sidste injektion og holder et år.
English: The safety of the vaccine was studied in two main laboratory safety studies and a field safety study carried out in cattle as well as two studies carried out in pregnant cows.
Danish: Vaccinens sikkerhed blev undersøgt i to hovedsikkerhedsundersøgelser i laboratorium og en feltsikkerhedsundersøgelse udført med kvæg samt to undersøgelser udført med drægtige køer.
English: The studies showed the vaccine prevents viraemia in cattle and offers protection for one year.
Danish: Undersøgelserne viste, at vaccinen forebygger viræmi hos kvæg, og at den giver beskyttelse i et år.
English: This will help to protect them against the disease.
Danish: Derved er dyrene bedre beskyttet mod sygdommen.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Zulvac 1 Bovis on 05/08/2011.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union Zulvac 1 Bovis den 5. august 2011.
English: The first injection is given from two and a half months of age and the second injection is given three weeks later.
Danish: Den første injektion gives, når dyret er 2,5 måneder gammelt, og den anden injektion gives tre uger senere.
English: In 2012 the CVMP considered that the submitted data were adequate for the authorisation of Zulvac 1 Bovis to convert to normal.
Danish: I 2012 konkluderede CVMP, at de forelagte oplysninger var tilstrækkelige for at kunne omdanne godkendelsen af Zulvac 1 Bovis til en normal godkendelse.
English: The vaccine is safe for cattle from two and a half months of age onwards and in pregnant cows.
Danish: Vaccinen er sikker for kvæg fra 2,5-månedersalderen og hos drægtige køer.
English: The studies aim was to establish the smallest dose of vaccine that prevented viraemia as well as the duration of protection for Zulvac 1 Bovis.
Danish: Målet med undersøgelserne var at fastslå den mindste vaccinedosis, der forebyggede viræmi, samt varigheden af beskyttelsen med Zulvac 1 Bovis.
English: When it is given to cattle, the immune system recognises the viruses as ‘foreign' and makes antibodies against them.
Danish: Når kvæget vaccineres, opfatter immunsystemet viraene som "fremmede" og producerer antistoffer mod dem.
English: In the future, if the animals are exposed to the bluetongue virus, their immune systems will be able to produce antibodies more quickly.
Danish: Hvis dyrene efterfølgende udsættes for bluetongue-vira, vil immunsystemet hurtigere kunne danne antistoffer mod dem.
English: The vaccine is used to prevent viraemia (the presence of the viruses in the blood) in cattle from two and a half months of age.
Danish: Vaccinen anvendes til at forebygge viræmi (tilstedeværelse af virus i blodet) hos kvæg fra 2,5-månedersalderen.
English: Inactivated vaccine against Bluetongue virus, serotype 1
Danish: Inaktiveret vaccine mod bluetongue-virus, serotype 1
English: Zulvac 1 Bovis contains bluetongue virus of one serotype (serotype 1).
Danish: Zulvac 1 Bovis indeholder bluetongue-virus af én serotype (serotype 1).
English: The effectiveness of the vaccine was studied in three main laboratory studies in calves where animals were challenged with bluetongue virus serotype 1, after receiving Zulvac 1 Bovis vaccine containing different amounts of virus.
Danish: Vaccinens virkning blev undersøgt i tre hovedundersøgelser i laboratorium, hvor kalve blev udsat for bluetongue-virus, serotype 1, efter at have fået Zulvac 1 Bovis-vaccine med forskellige mængder virus.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Zulvac 1 Bovis exceed the risks in the prevention of viraemia caused by bluetongue virus, serotype 1 in cattle from two and a half months of age.
Danish: Udvalget for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved Zulvac 1 Bovis opvejer risiciene ved forebyggelse af viræmi forårsaget af bluetongue-virus, serotype 1, hos kvæg fra 2,5månedersalderen.
English: This means that it was not possible to obtain complete information about Zulvac 1 Bovis at the time of the initial authorisation.
Danish: Det betyder, at det på tidspunktet for den oprindelige godkendelse ikke var muligt at indhente fyldestgørende oplysninger om Zulvac 1 Bovis.
English: Zulvac 1 Bovis is a vaccine.
Danish: Zulvac 1 Bovis er en vaccine.
English: Zulvac 1 Bovis is used in cattle to protect them against bluetongue disease, an infection caused by the bluetongue virus which is transmitted by midges .
Danish: Zulvac 1 Bovis anvendes til kvæg som beskyttelse mod sygdommen bluetongue, en infektion forårsaget af bluetongue-virus, der overføres gennem mitter.
English: Zulvac 1 Bovis contains bluetongue viruses that have been inactivated so that they cannot cause the disease.
Danish: Zulvac 1 Bovis indeholder bluetongue-vira, som er blevet inaktiveret, så de ikke kan fremkalde sygdommen.
English: Other information about Zulvac 1 Bovis:
Danish: Andre oplysninger om Zulvac 1 Bovis:
English: Zulvac 1 Bovis is a vaccine that is available as a suspension for injection.
Danish: Zulvac 1 Bovis er en vaccine, der fås som en suspension til injektion.
English: It contains inactivated (killed) bluetongue serotype 1 virus.
Danish: Den indeholder inaktiveret (dræbt) bluetongue-virus, serotype 1.
English: What is the risk associated with ZULVAC 1 Bovis?
Danish: Hvilken risiko er der forbundet med Zulvac 1 Bovis?
English: Why has Zulvac 1 Bovis been approved?
Danish: Hvorfor blev Zulvac 1 Bovis godkendt?
English: What is Zulvac 1 Bovis?
Danish: Hvad er Zulvac 1 Bovis?
English: How has Zulvac 1 Bovis been studied?
Danish: Hvordan blev Zulvac 1 Bovis undersøgt?
English: What is ZULVAC 1 Bovis used for?
Danish: Hvad anvendes Zulvac 1 Bovis til?
English: How does Zulvac 1 Bovis work?
Danish: Hvordan virker Zulvac 1 Bovis?
English: What benefit has Zulvac 1 Bovis shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Zulvac 1 Bovis?
English: Date of first authorisation: 19 November 2015
Danish: Dato for første markedsføringstilladelse: 19. november 2015
English: PC: {number} SN: {number} NN: {number} [Outer packaging only]
Danish: PC: {nummer} SN: {nummer} NN: {nummer} [kun på den ydre emballage]
English: ATC code: J05AR18.
Danish: ATC-kode: J05AR18.
English: Disproportionality analysis did not highlight events that met the criteria for signal of disproportionate reporting.
Danish: En disproportionalitetsanalyse fremhævede ikke hændelser, der opfyldte kriterierne for signal af disproportional rapportering.
English: 3 These are medicinal products within class where similar interactions could be predicted.
Danish: 3 Disse er lægemidler i samme klasse, hvor lignende interaktioner kunne forudsiges.
English: NC = not calculated
Danish: NC = ikke beregnet
English: • If you are taking one of these medicines:
Danish: • Hvis De tager et af disse lægemidler:
English: Data are presented as mean (%CV).
Danish: Data vises som gennemsnit (% CV).
English: Genvoya contains four active substances:
Danish: Genvoya indeholder fire aktive stoffer:
English: Since the previous review, 6 new cases were identified (5 valid and 1 invalid).
Danish: 6 nye tilfælde er blevet identificeret siden den forrige gennemgang (5 gyldige og 1 ugyldig).
English: Age, gender, and ethnicity
Danish: Alder, køn og etnicitet
English: Patients were stratified by prior treatment regimen.
Danish: Patienterne blev stratificeret ved tidligere behandlingsregime.
English: The amount of this medicine in your blood may decrease during pregnancy which may stop it from working properly.
Danish: Mængden af dette lægemiddel i Deres blod kan falde under graviditet, hvilket kan forhindre det i at virke korrekt.
English: Alternative endothelin receptor antagonists may be considered.
Danish: Alternative endothelin receptorantagonister kan overvejes.
English: The dose of clarithromycin should be reduced by 50%.
Danish: Dosis af clarithromycin bør reduceres med 50 %.
English: Table 1: Interactions between the individual components of Genvoya and other medicinal products
Danish: Tabel 1: Interaktion mellem Genvoyas individuelle komponenter og andre lægemidler
English: 7 This study was conducted with additional voxilaprevir 100 mg to achieve voxilaprevir exposures expected in
Danish: 7 Dette studie blev udført med yderligere 100 mg voxilaprevir for at opnå de voxilaprevir-eksponeringer, der forventes hos
English: Adults: one tablet each day with food
Danish: Voksne: en tablet om dagen sammen med mad
English: Expected Drospirenone: AUC: ↑
Danish: Forventet Drospirenon: AUC: ↑
English: If Genvoya has been prescribed for your child, please note that all the information in this leaflet is addressed to your child (in this case please read “your child” instead of “you”).
Danish: Hvis Deres barn er blevet ordineret Genvoya, skal De bemærke, at alle oplysninger i denne indlægsseddel er henvendt til Deres barn (i dette tilfælde skal det læses som ”Deres barn” i stedet for ”De”).
English: • contraceptive pill, used to prevent pregnancy
Danish: • p-piller, anvendes til at forebygge graviditet
English: < 50 years ≥ 50 years
Danish: Alder < 50 år ≥ 50 år
English: 1 When data available from drug-drug interaction studies.
Danish: 1 Når data er tilgængelige fra lægemiddelinteraktionsstudier.
English: DOAC = direct oral anticoagulant
Danish: DOAK = direkte oral antikoagulant
English: Frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1,000 to
Danish: Hyppighed er defineret som følger: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10) og ikke almindelig (≥ 1/1.000
English: HCV infected patients.
Danish: HCV-inficerede patienter.
English: b Week 96 window was between Day 630 and 713 (inclusive).
Danish: b Uge 96-vinduet var fra dag 630 til 713 (inklusive).
English: Talk to your doctor if you are taking:
Danish: Kontakt lægen, hvis De tager:
English: With other sedatives/hypnotics, dose reduction may be necessary and concentration monitoring is recommended.
Danish: Med andre sedativa/hypnotika kan en dosisreduktion være nødvendig, og det anbefales at overvåge koncentrationen.
English: Other types of medicine:
Danish: Andre former for lægemidler:
English: This leaflet was last revised in <{MM/YYYY}> <{month YYYY}>
Danish: Denne indlægsseddel blev senest ændret <{MM/ÅÅÅÅ}> <{måned ÅÅÅÅ}>
English: • If you are intolerant to lactose (see Genvoya contains lactose later in this section).
Danish: • Hvis De er lactose-intolerant (se Genvoya indeholder lactose senere i dette punkt).
English: • corticosteroids including:
Danish: • kortikosteroider, herunder:
English: angioedema3,4, pruritus, urticaria4
Danish: angioødem3,4, pruritus, urticaria4
English: The long-term effects of substantial increases in progestogen exposure are unknown.
Danish: De langvarige virkninger af betydeligt øget progestogeneksponering er ukendte.
English: Take both halves of the tablet one after the other to get the full dose.
Danish: Tag begge halvdele af tabletten, den ene efter den anden, så De får den fulde dosis.
English: Studies conducted with other medicinal products
Danish: Studier, udført med andre lægemidler
English: If you have difficulty swallowing the tablet whole, you can split it in half.
Danish: Hvis det er svært at synke hele tabletten, kan den deles i halve.
English: Elvitegravir (simultaneous administration):
Danish: Elvitegravir (samtidig administration):
English: No patient qualified for resistance analysis through Week 48.
Danish: Ingen patienter var kvalificeredetil resistensanalyse ved 48 uger.
English: Do not use this medicine after the expiry date which is stated on the carton and bottle after {EXP}.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og tabletbeholderen efter (EXP).
English: The adverse reactions in Table 2 are listed by system organ class and frequency.
Danish: Bivirkningerne i tabel 2 er opstillet pr. systemorganklasse og hyppighed.
English: 2T = second trimester; 3T = third trimester; PP =postpartum a paired comparisons b P<0.10 compared with postpartum
Danish: 2T = andet trimester; 3T = tredje trimester; PP =postpartum a parrede sammenligninger b P<0,10 sammenlignet med postpartum
English: As a result, the amounts of Genvoya or other medicines in your blood may be affected.
Danish: Som et resultat heraf kan mængden af Genvoya eller anden medicin i Deres blod påvirkes.
English: For patients who are unable to swallow the tablet whole, the tablet may be split in half and both halves taken one after the other, ensuring that the full dose is taken.
Danish: Til patienter, der ikke kan synke hele tabletten, kan tabletten deles i halve og begge halvdele tages, den ene efter den anden, så det sikres at hele dosen tages.
English: There are no adequate and well-controlled studies of Genvoya or its components in pregnant women.
Danish: Der er ingen tilstrækkelige og velkontrollerede studier af Genvoya eller Genvoya-komponenter hos gravide kvinder.
English: Elvitegravir (antacid suspension after ± 2 hours):
Danish: Elvitegravir (antacidumsuspension efter ± 2 timer):
English: It is recommended that you do not breast-feed to avoid passing the virus to the baby in breast milk.
Danish: Det anbefales, at De ikke ammer for at undgå at overføre virus til barnet via mælken.
English: Pregnant women should not take Genvoya.
Danish: Gravide kvinder bør ikke tage Genvoya.
English: The use of Genvoya in children aged 5 years or under has not yet been studied.
Danish: Anvendelsen af Genvoya til børn i alderen 5 år eller derunder er ikke undersøgt endnu.
English: N/A = not applicable
Danish: N/A = ikke relevant
English: Treatment of overdose with Genvoya consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient.
Danish: Behandling af overdosering med Genvoya består af generel støttebehandling, herunder overvågning af vitale tegn og observation af patientens kliniske status.
English: At baseline, median eGFR was 56 mL/min.
Danish: Ved baseline var median eGFR 56 ml/min.
English: The cases evaluated in this review mostly occurred in patients with history of psychiatric events or other external factors reported that may have contributed to the event.
Danish: De evaluerede tilfælde i denne gennemgang forekom hovedsageligt hos patienter med psykiske hændelser i anamnesen eller med andre rapporterede eksterne faktorer, der kan have bidraget til hændelsen.
English: Assessment of adverse reactions is based on safety data from across all Phase 2 and 3 studies in which 2,396 patients received Genvoya and from post-marketing experience.
Danish: Vurderingen af bivirkninger er baseret på sikkerhedsdata fra alle fase 2- og 3-studier, hvor 2.396 patienter fik Genvoya samt på erfaringer efter markedsføring.
English: When treating HIV infection, it is not always possible to tell whether some of the unwanted effects are caused by Genvoya or by other medicines that you are taking at the same time, or by the HIV disease itself.
Danish: Når hiv-infektion behandles, er det ikke altid muligt at afgøre, om nogle af de uønskede virkninger er forårsaget af Genvoya eller af anden medicin, som De tager samtidigt, eller af selve hiv-sygdommen.
English: It should be kept in mind that a twice weekly dose of 150 mg may not provide an optimal exposure to rifabutin thus leading to a risk of rifamycin resistance and a treatment failure.
Danish: Det bør overvejes, at en dosis på 150 mg to gange ugentligt måske ikke giver en optimal eksponering over for rifabutin, hvilket i så fald fører til en risiko for resistens over for rifamycin og behandlingssvigt.
English: 5 This study was conducted using Genvoya.
Danish: 5 Dette studie blev udført med Genvoya.
English: In these 2 patients, no amino acid substitutions associated with resistance to any of the components of Genvoya were identified in HIV-1 or HBV.
Danish: Hos disse 2 patienter blev ingen aminosyresubstitutioner forbundet med resistens over for nogen af komponenterne i Genvoya identificeret i hiv-1 eller HBV.
English: (may affect more than 1 in 10 people) • feeling sick (nausea)
Danish: (kan forekomme hos flere end 1 ud af 10 personer) • kvalme
English: Pooled treatment outcomes at 48 and 144 weeks are shown in Table 3.
Danish: Samlede behandlingsresultater efter 48 og 144 uger vises i tabel 3.
English: See sections 4.2, 4.4 and 5.1.
Danish: 4.2, 4.4 og 5.1.
English: • Use effective contraception while taking Genvoya.
Danish: • Anvend effektiv prævention, mens De tager Genvoya.
English: There are no data on fertility from the use of Genvoya in humans.
Danish: Der foreligger ingen data om fertilitet fra anvendelsen af Genvoya til mennesker.
English: Pregnancy and postpartum
Danish: Graviditet og postpartum
English: Careful dose titration of the antidepressant and monitoring for antidepressant response is recommended.
Danish: Der anbefales en forsigtig dosistitrering af det antidepressive lægemiddel og overvågning for det antidepressive respons.
English: • In children aged from 6 years and with body weight at least 25 kg for whom alternative regimens are unsuitable due to toxicities.
Danish: • Hos børn i alderen fra 6 år, med en legemsvægt på mindst 25 kg, for hvem andre regimer er uegnede på grund af toksiciteter.
English: Changes in lipid laboratory tests
Danish: Ændringer i laboratorieprøver for lipider
English: Study GS-US-292-1515
Danish: Studie GS-US-292-1515
English: Stopping Genvoya can seriously affect your response to future treatment.
Danish: Genvoya, kan det i alvorlig grad påvirke Deres reaktion på fremtidig behandling.
English: Emtricitabine can be removed by haemodialysis, which removes approximately 30% of the emtricitabine dose over a 3 hour dialysis period starting within 1.5 hours of emtricitabine dosing.
Danish: Emtricitabin kan fjernes ved hæmodialyse, der fjerner ca. 30 % af emtricitabindosis i løbet af en 3 timers dialyseperiode, der starter inden for 1,5 timer efter emtricitabindosering.
English: Look out for any symptoms of infection or other symptoms such as: muscle weakness weakness beginning in the hands and feet and moving up towards the trunk of the body palpitations, tremor or hyperactivity.
Danish: Vær opmærksom på symptomer på infektion eller andre symptomer, såsom: muskelsvaghed svaghed, der begynder i hænder og fødder og bevæger sig op mod selve kroppen hjertebanken, rysten eller hyperaktivitet.
English: If you have both HIV infection and hepatitis B, it is especially important not to stop your Genvoya treatment without talking to your doctor first.
Danish: Hvis De har både hiv-infektion og hepatitis B, er det særlig vigtigt ikke at ophøre med behandlingen med Genvoya uden først at konsultere Deres læge.
English: Tenofovir is efficiently removed by haemodialysis with an extraction coefficient of approximately 54%.
Danish: Tenofovir fjernes effektivt ved hæmodialyse med en ekstraktionskoefficient på ca. 54 %.
English: Integrase is an HIV-1 encoded enzyme that is required for viral replication.
Danish: Integrase er et hiv 1-kodet enzym, der er nødvendigt for viral replikation.
English: No data are available to make dose recommendations in children aged less than 12 years with renal impairment or in children less than 18 years with end stage renal disease.
Danish: Der er ingen data tilgængelige til at lave dosisanbefalinger hos børn i alderen under 12 år med nedsat nyrefunktion eller hos børn under 18 år med nyresygdom i slutstadiet.
English: FOOD SUPPLEMENTS Multivitamin supplements
Danish: KOSTTILSKUD Multivitamin-tilskud
English: Medicines that must never be taken with Genvoya:
Danish: Lægemidler, der aldrig må tages sammen med Genvoya:
English: Pharmacotherapeutic group: Antivirals for systemic use; antivirals for treatment of HIV infections, combinations.
Danish: Farmakoterapeutisk klassifikation: Antivirale midler til systemisk brug; antivirale midler til behandling af hiv-infektioner, kombinationer.
English: The safety profile in paediatric patients who received treatment with Genvoya was similar to that in adults.
Danish: Sikkerhedsprofilen hos pædiatriske patienter, der fik behandling med Genvoya, lignede den for voksne.
English: Genvoya should be taken orally, once daily with food (see section 5.2).
Danish: Genvoya skal tages oralt, én gang dagligt, sammen med mad (se pkt.
English: 30 film-coated tablets 30 tablets
Danish: 30 filmovertrukne tabletter 30 tabletter
English: However increased post-implantation loss and decreased foetal weights were observed in rats associated with significant decreases in maternal body weights at 125 mg/kg/day.
Danish: Der blev imidlertid observeret øget postimplantationstab og nedsat fødselsvægt hos rotter, forbundet med signifikante reduktioner i moderens kropsvægt ved 125 mg/kg/dag.
English: INHALED BETA AGONIST Salmeterol
Danish: INHALERET BETA-AGONIST Salmeterol
English: Comparison to paired postpartum data, n
Danish: Sammenligning med parrede postpartumdata, n
English:  Tell your doctor if you are taking these or any other medicines.
Danish:  Fortæl lægen, hvis De tager disse eller anden medicin.
English: If you have hepatitis B infection, liver problems may become worse after you stop taking Genvoya.
Danish: Hvis De har en hepatitis B-infektion, kan leverproblemerne blive værre, efter De holder op med at tage Genvoya.
English: Children aged 8 to < 12 years, > 25 kg
Danish: Børn i alderen 8 til < 12 år, > 25 kg
English: If you are on dialysis, take your daily dose of Genvoya following completion of dialysis.
Danish: Hvis De er i dialyse, skal De tage Deres daglige dosis af Genvoya efter afslutning af dialysen.
English: While taking Genvoya you may still develop infections or other illnesses associated with HIV infection.
Danish: Mens De tager Genvoya, kan De stadig udvikle infektioner eller andre sygdomme, der er forbundet med hiv-infektion.