FrancophonIA/ELRC3.0 huggingface dataset:
English: In studies with nucleoside naive patients, on treatment ALT elevations >10 times ULN and >2 times baseline occurred in 2% of entecavir treated patients vs 4% of lamivudine treated patients.
Danish: I studier med patienter, der ikke tidligere har været behandlet med nukleosid, sås under behandling ALAT-stigninger >10 gange ULN og >2 gange baseline hos 2% af de entecavir-behandlede patienter versus 4% af de lamivudin-behandlede patienter.
English: HBeAg positive (study 022): treatment with entecavir for up to 96 weeks (n = 354) resulted in cumulative response rates of 80% for HBV DNA <300 copies/ml by PCR, 87% for ALT normalisation, 31% for HBeAg seroconversion and 2% for HBsAg seroconversion (5% for HBsAg loss).
Danish: HBeAg-positive (studie 022): Behandling med entecavir i op til 96 uger (n = 354) gav kumulative responsrater på 80% for HBV-DNA <300 kopier/ml ved PCR, 87% for ALAT-normalisering, 31% for HBeAg-serokonvertering og 2% for HBsAg-serokonvertering (5% for tab af HBsAg).
English: In a small percentage of lamivudine-refractory patients, ETVr substitutions at residues rtT184, rtS202 or rtM250 were present at baseline.
Danish: ETVr-substitutioner er set ved segment rtT184, rtS202 eller rtM250 ved baseline.
English: HIV/HBV co-infected patients receiving concomitant antiretroviral therapy
Danish: hiv/HBV-inficerede patienter, som samtidig får antiretroviral behandling
English: Spontaneous exacerbations in chronic hepatitis B are relatively common and are characterised by transient increases in serum ALT. After initiating antiviral therapy, serum ALT may increase in some patients as serum HBV DNA levels decline (see section 4.8).
Danish: Efter påbegyndelse af antiviral behandling, kan serum-ALAT stige hos nogle patienter i takt med, at serum-HBV-DNA falder (se pkt.
English: Genotypic Entecavir Resistance Through Year 5, Lamivudine-Refractory Studies Year 1 Year 2 Year 3a
Danish: Opståen af entecavir genotype-resistens til og med År 5, lamivudin-refraktære studier
English: Not all patients need to take the same dose of Entecavir Mylan.
Danish: Dosis af Entecavir Mylan er ikke den samme til alle patienter.
English: Viral load reduction (log10 copies/ml)c HBV DNA undetectable (<300 copies/ml by PCR)c
Danish: Fald i viral load (log10 kopier/ml)c HBV-DNA kan ikke påvises (<300 kopier/ml ved PCR)c ALAT-normalisering (≤1 gang ULN)
English: How to take Entecavir Mylan
Danish: Sådan skal du tage Entecavir Mylan
English: * for doses <0.5 mg entecavir oral solution is recommended ** on haemodialysis days, administer entecavir after haemodialysis.
Danish: * ved doser <0,5 mg entcavir anbefales oral opløsning.
English: HIV/HBV co-infected patients not receiving concomitant HAART
Danish: hiv/HBV-inficerede patienter, som ikke samtidig får HAART-behandling
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE ETIKET TIL BEHOLDER
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains entecavir monohydrate equivalent to 0.5 mg entecavir 3.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder entecavirmonohydrat svarende til 0,5 mg entecavir.
English: Year 4 a Year 5 a
Danish: År 5a
English: At end of dosing, among patients who continued treatment beyond 52 weeks (median of 96 weeks), 81% of 243 entecavir-treated and 39% of 164 lamivudine-treated patients had HBV DNA <300 copies/ml by PCR while ALT normalisation (≤1 times ULN) occurred in 79% of entecavirtreated and 68% of lamivudine-treated patients.
Danish: Blandt patienter, som fortsatte behandling ud over 52 uger (i gennemsnit 96 uger), havde 81% af de 243 entecavir-behandlede og 39% af de 164 lamivudin-behandlede patienter HBV-DNA <300 kopier/ml ved PCR ved behandlingens afslutning.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains entecavir monohydrate equivalent to 1 mg entecavir 3.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder entecavirmonohydrat svarende til 1 mg entecavir.
English: Mean serum HBV DNA by PCR was 7.83 log10 copies/ml and mean serum ALT was 100 U/l; 54% of patients were HBeAg positive, and 35% of patients had LVDr substitutions at baseline.
Danish: Gennemsnitlig serum-HBV-DNA ved PCR var 7,83 log10 kopier/ml, og gennemsnitlig serum-ALAT var 100 E/l.
English: 0.5 mg: the film-coated tablets (tablets) are white, film-coated, round, biconvex, beveled edge tablet debossed with “M” on one side and “EA” on the other side.
Danish: 0,5 mg: De filmovertrukne tabletter (tabletter) er hvide, filmovertrukne, runde, bikonvekse tabletter med afrundet kant og præget med ”M” på den ene side og ”EA” på den anden side.
English: HIV/HBV co-infected patients receiving concomitant HAART
Danish: hiv/HBV-inficerede patienter, som samtidig får HAART-behandling
English: 1 mg: the film-coated tablets (tablets) are white, film-coated, round, biconvex, beveled edge tablet debossed with “M” on one side and “EB” on the other side.
Danish: 1 mg: De filmovertrukne tabletter (tabletter) er hvide, filmovertrukne, runde, bikonvekse tabletter med afrundet kant og præget med ”M” på den ene side og ”EB” på den anden side.
English: Tabulated list of adverse reactions
Danish: Liste i tabelform over bivirkninger
English: 1 mg: white, film-coated, round, biconvex, beveled edge tablet debossed with “M” on one side and “EB” on the other side.
Danish: 1 mg: Hvid, filmovertrukket, rund, bikonveks tablet med afrundet kant og præget med ”M” på den ene side og ”EB” på den anden side.
English: NAME OF THE MEDICINAL PRODUCT Entecavir Mylan 0.5 mg tablets entecavir
Danish: Entecavir Mylan 0,5 mg tabletter entecavir
English: 0.5 mg: white, film-coated, round, biconvex, beveled edge tablet debossed with “M” on one side and “EA” on the other side.
Danish: 0,5 mg: Hvid, filmovertrukket, rund, bikonveks tablet med afrundet kant og præget med ”M” på den ene side og ”EA” på den anden side.
English: For patients originally assigned to entecavir treatment, the reduction in HBV DNA at 48 weeks was -4.20 log10 copies/ml, ALT normalisation had occurred in 37% of patients with abnormal baseline ALT and none achieved HBeAg seroconversion.
Danish: For patienter, der oprindelig blev allokeret til entecavir, var fald i HBV-DNA ved 48 uger4,20 log10 kopier/ml.
English: Entecavir Mylan 0.5 mg film-coated tablets Entecavir Mylan 1 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Entecavir Mylan 0,5 mg filmovertrukne tabletter Entecavir Mylan 1 mg filmovertrukne tabletter
English: Experience in nucleoside-naive patients with compensated liver disease
Danish: Erfaring hos patienter med kompenseret leversygdom, der ikke tidligere har været i nukleosidbehandling
English: NAME OF THE MEDICINAL PRODUCT Entecavir Mylan 1 mg film-coated tablets entecavir
Danish: Entecavir Mylan 1 mg filmovertrukne tabletter entecavir
English: NAME OF THE MEDICINAL PRODUCT Entecavir Mylan 0.5 mg film-coated tablets entecavir
Danish: Entecavir Mylan 0,5 mg filmovertrukne tabletter entecavir
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Entecavir Mylan Fortæl det altid til lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: Date of first authorisation: 11 January 2008 Date of latest renewal: 17 December 2012
Danish: Dato for første markedsføringstilladelse: 11. januar 2008 Dato for seneste fornyelse: 17. december 2012
English: Avamys has virtually no taste or smell.
Danish: Avamys har stort set ingen smag og ingen lugt.
English: In a small number of people, allergic reactions can develop into a more serious, even life-threatening problem if not treated.
Danish: Hos nogle få personer kan allergiske reaktioner udvikle sig til en alvorlig, endog livstruende situation, hvis de ikke behandles.
English: In many cases, these symptoms will be signs of less serious side effects.
Danish: Disse symptomer er i mange tilfælde tegn på mindre alvorlige bivirkninger.
English: Allergic reactions: get a doctor's help straight away
Danish: Ved allergiske reaktioner: Søg straks lægehjælp
English: • Blurred vision or temporary changes to vision with long term use.
Danish: • Sløret syn eller midlertidige ændringer i synet ved længerevarende brug.
English: Epistaxis *Epistaxis was generally mild to moderate in intensity.
Danish: Epistaxis *Epistaxis var generelt let til moderat i intensitet.
English: It is especially important to tell your doctor if you are taking, or have recently taken any of the following medicines:
Danish: Det er særligt vigtigt at fortælle lægen, hvis du tager eller lige har taget et af følgende lægemidler:
English: • Slowing of growth in children.
Danish: • Langsommere vækst hos børn.
English: • Use at the same time each day.
Danish: • på samme tidspunkt hver dag.
English: Six important things you need to know about using the nasal spray
Danish: Seks vigtige ting, du har behov for at vide om brug af næsesprayen
English: Following intravenous administration, the elimination phase half-life averaged 15.1 hours.
Danish: Efter intravenøs administration var den gennemsnitlige halveringstid 15,1 time.
English: After each use:
Danish: Hver gang du har brugt den:
English: **Growth retardation (see Clinical experience).
Danish: **Væksthæmning (se Klinisk erfaring)
English: You may also get streaks of blood when you blow your nose.
Danish: Du kan måske også opleve en smule blod, når du pudser næse.
English: Patients on ritonavir
Danish: Patienter der får ritonavir
English: Fertility There are no fertility data in humans.
Danish: Fertilitet Der foreligger ikke fertilitetsdata for mennesker.
English: This small increase in exposure did not result in a statistically significant difference in 24 hour serum cortisol levels between the two groups.
Danish: Denne lille forøgelse i eksponering resulterede ikke i en statistisk signifikant forskel i 24 timers serumkortisolkoncentrationerne mellem de to grupper.
English: Avamys should not be used at the same time with other nasal sprays containing steroids.
Danish: Avamys må ikke anvendes på samme tid med andre næsespray der indeholder steroider.
English: Eye disorders Not known
Danish: Øjne Ikke kendt
English: 2 Do not use water to clean it.
Danish: Brug ikke vand til rengøringen.
English: Acute overdose is unlikely to require any therapy other than observation.
Danish: Akut overdosering kræver ikke andre forholdsregler end observation.
English: In some patients benzalkonium chloride can cause irritation in the inside of the nose.
Danish: Hos nogle patienter kan benzalkoniumchlorid forårsage irritation i næsen.
English: This is important as Avamys is a thick suspension that becomes liquid when you shake it well - see picture b. It will only spray when it becomes liquid.
Danish: Dette er vigtigt, fordi Avamys er en tyk suspension, som bliver flydende, når du ryster den grundigt - se billede b. Den kan kun afgive et pust, når den er flydende.
English: • If you are allergic to fluticasone furoate or any of the other ingredients of this medicine (listed in section 6).
Danish: • Hvis du er allergisk over for det aktive stof eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: Further, there were no treatment-related increases in the incidence of tumours in two year inhalation studies in rats and mice.
Danish: Der var heller ingen behandlingsrelaterede stigninger i forekomst af tumorer ved to års inhalationsstudie hos rotter og mus.
English: • Use once a day
Danish: • én gang daglig
English: Allergic reactions to Avamys are rare and affect less than 1 person in 1,000.
Danish: Allergiske reaktioner over for Avamys er sjældne og kan forekomme hos færre end 1 ud af 1.000 personer.
English: In adults and adolescents, the incidence of epistaxis was higher in longer-term use (more than 6 weeks) than in short-term use (up to 6 weeks).
Danish: Hos voksne og unge var forekomsten af epistaxis hyppigere ved længere tids anvendelse (over 6 uger) end ved kort tids anvendelse (op til 6 uger).
English: Fluticasone furoate is widely distributed with volume of distribution at steady-state of, on average, 608 l.
Danish: Fluticasonfuroat fordeles bredt med et fordelingsvolumen ved steady-state på gennemsnitligt 608 l.
English: Onset of therapeutic benefit was observed as early as 8 hours after initial administration, with further improvement observed for several days afterwards.
Danish: Den terapeutiske virkning sås allerede 8 timer efter den første administration med yderligere forbedring i løbet af de følgende dage.
English: The following convention has been used for the classification of frequencies: Very common ≥1/10; Common ≥1/100 to <1/10; Uncommon ≥1/1000 to <1/100; Rare ≥1/10,000 to <1/1000; Very rare
Danish: Hyppigheden defineres således: meget almindelig (≥1/10); almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1.000 til <1/100); sjælden (≥1/10.000 til <1/1.000) og meget sjælden (<1/10.000).
English: Follow the guide carefully to get full benefit from using Avamys
Danish: Følg nøje vejledningen for at få fuldt udbytte af Avamys.
English: Frequency, type and severity of adverse reactions observed in the paediatric population are similar to those in the adult population.
Danish: Hyppigheden, typen og sværhedsgraden af bivirkninger, observeret i den pædiatriske population, svarer til bivirkningerne observeret hos voksne.
English: The plasma protein binding of fluticasone furoate is greater than 99 %.
Danish: Proteinbindingen af fluticasonfuroat i plasma er over 99 %.
English: Children under 6 years of age
Danish: Børn under 6 år
English: Urinary excretion accounted for approximately 1 % and 2 % of the orally and intravenously administered dose, respectively.
Danish: Udskillelse via urinen omfattede ca. 1 % og 2 % af henholdsvis den orale og intravenøse dosis.
English: • Avamys comes in an amber glass bottle.
Danish: • Avamys er i en brun glasflaske.
English: 3 years In-use shelf life: 2 months
Danish: 3 år Efter anbrud: 2 måneder
English: In addition, consideration should be given to referring the patient to a paediatric specialist (see section
Danish: Det bør desuden overvejes at henvise patienten til pædiater (se pkt.
English: If you are pregnant or breast-feeding, think you may be pregnant or a planning to have a baby, ask your doctor for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du bruger dette lægemiddel.
English: Don't exceed the recommended dose.
Danish: Du må ikke bruge mere end den anbefalede dosis.
English: Your doctor may wish to monitor you carefully if you are taking any of these medicines as they may increase the side effects of Avamys.
Danish: Lægen kan vælge at følge dig tæt, hvis du tager et af disse lægemidler, da de kan øge bivirkningerne af Avamys.
English: You will be able to see the liquid level for a new 30 or 60 spray bottle, but not in a new 120 spray bottle because the liquid level is above the window.
Danish: Det er muligt at se væskestanden i en ny spray med 30 eller 60 doser, men ikke i en ny flaske med 120 doser, fordi væsken står over vinduet.
English: This will treat your symptoms throughout the day and night.
Danish: På denne måde bliver dine symptomer behandlet døgnet rundt.
English: Tell your doctor if you had these conditions in the past, or if you notice blurred vision or other visual disturbances while you are taking Avamys.
Danish: Du skal fortælle lægen, hvis du tidligere har haft en af disse øjenlidelser, eller hvis du bemærker sløret syn eller andre synsforstyrrelser, mens du er i behandling med Avamys.
English: There are no adequate data from the use of fluticasone furoate in pregnant women.
Danish: Der foreligger ikke tilstrækkelige data om brugen af fluticasonfuroat hos gravide kvinder.
English: • If you have difficulty pressing the button with your thumb, you can use two hands - see picture d
Danish: • Hvis du har problemer med at presse dosisknappen ind med tommelfingeren, kan du bruge begge hænder - se billede d.
English: Avamys is indicated in adults, adolescents and children (6 years and over)
Danish: Avamys er indiceret til voksne, unge og børn (fra 6 år)
English: Avamys contains benzalkonium chloride
Danish: Avamys indeholder benzalkoniumchlorid
English: Look at the level through the window.
Danish: Kig på væskestanden gennem vinduet.
English: Your doctor will assess whether you should take Avamys with these medicines.
Danish: Lægen vil vurdere, om du kan bruge Avamys sammen med disse lægemidler.
English: Less than 1 % of dose-related material is excreted in urine and therefore renal impairment would not be expected to affect the pharmacokinetics of fluticasone furoate.
Danish: Mindre end 1 % af det dosisrelaterede materiale udskilles med urinen, og nedsat nyrefunktion forventes derfor ikke at påvirke fluticasonfuroats farmakokinetik.
English: Nasal ulceration
Danish: Nasale ulcerationer
English: • Try to reset it by following the instructions under ‘Preparing the nasal spray for use'.
Danish: • Prøv at få den til at virke ved at følge vejledningen under ”Klargøring af næsesprayen”.
English: Safety and efficacy in this group has not been well established.
Danish: Sikkerhed og effekt er ikke tilstrækkeligt dokumenteret.
English: The primary outcomes [time to increase in posterior subcapsular opacity (0.3 from baseline in Lens Opacities Classification System, Version III (LOCS III grade)) and time to increase in intraocular pressure (IOP; 7 mmHg from baseline)] were not statistically significant between the two groups.
Danish: De primære resultater (tid til stigning i posterior subkapsulær opacitet ( 0,3 fra baseline i Lens Opacities Classification System, version III (LOCS III grad)) og tid til stigning i det intraokulære tryk (IOP;  7 mmHg fra baseline) var ikke statistisk signifikante mellem de to grupper.
English: If you do, rinse your eyes with water.
Danish: Skyl øjnene med vand, hvis det skulle ske.
English: If the nasal spray does not seem to be working:
Danish: Hvis næsesprayen ikke fungerer korrekt:
English: The doctor will check your child's height regularly, and make sure he or she is taking the lowest possible effective dose.
Danish: Lægen vil jævnligt måle højden på dit barn og sørge for, at han eller hun får den mindste dosis, der holder allergien under kontrol.
English: These effects are much less likely to occur than with oral corticosteroids and may vary in individual patients and between different corticosteroid preparations.
Danish: Disse bivirkninger er langt mindre sandsynlige end ved oral steroidbehandling og kan variere fra patient til patient og mellem forskellige kortikosteroidpræparater.
English: Tell your doctor or pharmacist if you feel discomfort when using the spray.
Danish: Fortæl det til lægen eller på apoteket, hvis det føles ubehageligt at bruge sprayen.
English: Children and adolescents Do not use in children under 6 years old.
Danish: Børn og unge Må ikke anvendes til børn under 6 år.
English: Findings in general toxicology studies were similar to those observed with other glucocorticoids and are associated with exaggerated pharmacological activity.
Danish: Fund i generelle toksikologiske studier svarede til dem, der sås med andre glukokortikoider, og tilskrives overdrevet farmakologisk aktivitet.
English: Nasal spray, suspension 1 bottle - 30 sprays 1 bottle - 60 sprays 1 bottle - 120 sprays
Danish: Næsespray, suspension 1 flaske - 30 pust 1 flaske - 60 pust 1 flaske - 120 pust
English: Coadministration should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side effects, in which case patients should be monitored for systemic corticosteroid side effects.
Danish: Samtidig behandling bør undgås medmindre fordelene overstiger den øgede risiko for systemiske kortikosteroide bivirkninger, i sådanne tilfælde bør patienten monitoreres for systemiske kortikosteroide bivirkninger.
English: If the level is very low there may not be enough left to work the nasal spray.
Danish: Hvis væsken står meget lavt, er der muligvis ikke nok tilbage til at få et pust ud.
English: Very common side effects (may affect more than 1 in 10 people) • Nosebleeds (generally minor), particularly if you use Avamys for more than 6 weeks continuously.
Danish: Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 personer) • Næseblod (som regel let), især hvis du bruger Avamys i mere end 6 uger.
English: Avamys has no or negligible influence on the ability to drive and use machines.
Danish: Avamys påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: It is sprayed into the nose as a fine mist.
Danish: Det sprøjtes ind i næsen som en fint forstøvet væske.
English: Data from large clinical trials were used to determine the frequency of adverse reactions.
Danish: Der er anvendt data fra store kliniske studier til bestemmelse af hyppigheden af bivirkninger.
English: Avamys is indicated for the treatment of the symptoms of allergic rhinitis.
Danish: Avamys er indiceret til behandling af symptomer på allergisk rhinitis.
English: However, it may take several days of treatment to achieve maximum benefit, and the patient should be informed that their symptoms will improve with continuous regular use (see section 5.1).
Danish: Det kan imidlertid tage flere dage, før der opnås optimal virkning, og patienten skal orienteres om, at vedvarende behandling giver bedst effekt (se pkt.
English: Tell your doctor or pharmacist if you are taking, or have recently taken, or might take any other medicines, including medicines obtained without a prescription.
Danish: Fortæl altid lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig, herunder medicin købt uden recept
English: Epistaxis *In paediatric clinical studies of up to 12 weeks duration the incidence of epistaxis was similar between patients receiving fluticasone furoate and patients receiving placebo.
Danish: Epistaxis * I pædiatriske kliniske studier af op til 12 ugers varighed var forekomsten af epistaxis den samme hos patienter, der fik fluticasonfuroat, og hos patienter, der fik placebo.
English: Fluticasone furoate should be used in pregnancy only if the benefits to the mother outweigh the potential risks to the foetus or child.
Danish: Fluticasonfuroat bør kun anvendes under graviditet, hvis fordelene for moderen opvejer de eventuelle risici for fostret eller barnet.
English: 6 Take the nozzle out and breathe out through your mouth.
Danish: Fjern næsesprayen fra næsen og pust ud gennem munden.
English: • ritonavir or cobicistat, used to treat HIV
Danish: • ritonavir eller cobicistat (medicin mod hiv)
English: • steroid creams
Danish: • steroidcreme
English: • If you think the nozzle may be blocked, don't use a pin or anything sharp to clear it.
Danish: • Hvis du tror, næsestudsen kan være tilstoppet, må du ikke bruge en nål eller noget skarpt for at få hul igennem.
English: At weeks 52 and 104, the majority of subjects (>95%) had IOP values of within ± 5mmHg of the baseline value.
Danish: Ved uge 52 og 104 havde størstedelen (> 95 %) IOP-værdier indenfor ± 5 mmHg fra baseline-værdi.
English: Growth retardation
Danish: Væksthæmning
English: The nasal spray is now ready for use.
Danish: Næsesprayen er nu klar til brug.
English: • may cause eye conditions such as glaucoma (increase in pressure in the eye) or cataracts (clouding of the lens of the eye).
Danish: • kan være årsag til glaukom (grøn stær øget tryk i øjet) eller katarakt (grå stær sløret syn).
English: In children this side effect can cause them to grow more slowly than others.
Danish: Hos børn kan denne bivirkning medføre langsommere vækst.
English: The safety in children under 6 years has not been well established.
Danish: Sikkerheden hos børn under 6 år er ikke tilstrækkeligt dokumenteret.
English: GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus Dublin 24, Ireland
Danish: GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus Dublin 24, Irland