FrancophonIA/ELRC3.0 huggingface dataset:
English: The main measure of effectiveness was a reduction in scores for lung fluid and cough (both are signs of congestive heart failure) after 14 days of treatment and no worsening of difficulty in breathing or exercise intolerance scores.
Danish: Virkningen blev hovedsageligt bedømt på faldet i scorerne for lungevæske og hoste (som begge er tegn på kongestivt hjertesvigt) efter 14 dages behandling og ingen forværring af scorerne for vejrtrækningsbesvær og motionsintolerans.
English: For more information about using Isemid, see the package leaflet or contact your veterinarian or pharmacist.
Danish: Hvis du ønsker flere oplysninger om anvendelsen af Isemid, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: This can lead to exercise intolerance (inability to carry out physical activity), difficulty breathing and fluid retention.
Danish: Dette kan medføre manglende evne til fysisk aktivitet (motionsintolerans), vejrtrækningsbesvær og væskeophobning.
English: What benefits of Isemid have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Isemid?
English: Isemid must not be given in cases of kidney failure, dehydration, a decrease in circulating blood volume or low blood pressure.
Danish: Isemid må ikke gives ved nyresvigt, dehydrering, for lav blodvolumen eller lavt blodtryk.
English: For the full list of side effects and restrictions of Isemid, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved og begrænsninger for Isemid fremgår af indlægssedlen.
English: Isemid is a veterinary medicine used to treat signs related to congestive heart failure in dogs.
Danish: Isemid er et lægemiddel til dyr, der anvendes til behandling af symptomer på kongestivt hjertesvigt hos hunde.
English: How is Isemid used?
Danish: Hvordan anvendes Isemid?
English: Isemid to be as least as effective as furosemide for the treatment of signs related to congestive heart failure with 74% of dogs in each group being successfully treated.
Danish: furosemid til behandling af tegn på kongestivt hjertesvigt, og hos 74 % af hundene i hver gruppe var behandlingen vellykket.
English: Isemid may increase urination, and lead to thirst, gut disturbances, low blood pressure and dehydration if ingested.
Danish: Isemid kan give øget vandladning og medføre tørst, forstyrrelser i mavetarmsystemet, lavt blodtryk og dehydrering ved indtagelse.
English: If symptoms of allergy occur, the advice of a doctor should be sought immediately and the package leaflet or label shown to the doctor.
Danish: Søg omgående lægehjælp, hvis der opstår symptomer på allergi, og vis indlægssedlen eller etiketten til lægen.
English: How does Isemid work?
Danish: Hvordan virker Isemid?
English: The study showed
Danish: Studiet viste, at Isemid var mindst lige så effektivt som
English: It is usually given into your arm over about 30 minutes.
Danish: Det gives normalt i armen over ca. 30 minutter.
English: • seeing, hearing or feeling things which are not there
Danish: • se, høre eller føle ting der ikke er der
English: From a microbiological point of view, the product should be used immediately.
Danish: Ud fra et mikrobiologisk synspunkt skal lægemidlet anvendes straks.
English: There is 1 vial in each pack.
Danish: Der er 1 hætteglas i hver pakning.
English: It is used when other flu treatments are not suitable.
Danish: Det bruges, når andre influenzabehandlinger ikke er egnede.
English: Risk of bacterial infections
Danish: Risiko for bakterieinfektioner
English: Resistance in immunocompromised patients
Danish: Resistens hos immunkompromitterede patienter
English: • being less alert or not responding to loud sounds or being shaken
Danish: • at være mindre opmærksom eller ikke respondere på høje lyde eller på at blive rystet.
English: Your dose may be increased or decreased depending on how well you respond to treatment.
Danish: Din dosis kan blive sat op eller ned, afhængigt af hvor godt du reagerer på behandlingen.
English: Influenza can be associated with a variety of neurological and behavioural symptoms.
Danish: Influenza kan være forbundet med en række neurologiske og adfærdsmæssige symptomer.
English: The primary analysis was performed on the Influenza Positive Population (IPP) comprised of 488 patients.
Danish: Den primære analyse blev udført på den influenzapositive population (IPP), som bestod af 488 patienter.
English: Dectova is administered by intravenous infusion over 30 minutes.
Danish: Dectova administreres ved intravenøs infusion over 30 minutter.
English: Eligible patients were not to have had >3 days of prior antiviral treatment.
Danish: Egnede patienter måtte ikke have fået > 3 dages forudgående antiviral behandling.
English: However, there is no information on placental transfer in humans.
Danish: Der foreligger dog ingen oplysninger om placental overførsel hos mennesker.
English: Dectova should be used in accordance with official guidance.
Danish: Dectova bør anvendes i henhold til officielle retningslinjer.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given 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 får dette lægemiddel.
English: If your kidneys are not working as well as they should, your doctor will decide on the reduced dose for you.
Danish: Hvis dine nyrer ikke fungerer så godt, som de burde, vil lægen fastsætte en nedsat dosis til dig.
English: All patients must have their renal function assessed before and regularly during treatment.
Danish: Alle patienter skal have bestemt deres nyrefunktion før og regelmæssigt under behandling.
English: There is no specific antidote to treat an overdose of this medicine.
Danish: Der findes ingen specifik antidot til behandling af overdosering med dette lægemiddel.
English: The initial 5 day treatment course could be extended for up to 5 additional days if clinical symptoms or patient characteristics warranted further treatment.
Danish: Det indledende 5-dages behandlingsforløb kunne forlænges med op til 5 ekstra dage, hvis de kliniske symptomer eller patientens karakteristika gav basis for yderligere behandling.
English: Annual reports to be submitted
Danish: Årlig rapport skal indsendes
English: Elderly No dose adjustment is required based on age.
Danish: Ældre Det er ikke nødvendigt at justere dosis på grund af alder.
English: • Use aseptic techniques throughout preparation of the dose.
Danish: • Anvend aseptisk teknik under hele klargøringen af dosis.
English: There are limited data from the use of zanamivir in pregnant women.
Danish: Der er begrænsede data fra anvendelse af zanamivir til gravide kvinder.
English: • The infusion bag should be gently manipulated by hand to ensure it is mixed thoroughly.
Danish: • Infusionsposen skal manipuleres forsigtigt med hånden for at sikre, at indholdet er blandet grundigt.
English: In vitro activity
Danish: In vitro-aktivitet
English: Some people may also have hallucinations (seeing, hearing, or feeling things that are not there) or fits (seizures) which can lead to loss of consciousness.
Danish: Nogle mennesker kan også få hallucinationer (se, høre eller føle ting, som ikke er der) eller krampeanfald, som kan føre til, at de mister bevidstheden.
English: This medicine has been authorised under ‘exceptional circumstances'.
Danish: Dette lægemiddel er godkendt under "særlige vilkår".
English: Treatment of an overdose should consist of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient.
Danish: Behandling af overdosering bør bestå i almindelig understøttende behandling, herunder monitorering af vitale tegn og observation af patientens kliniske status.
English: The median patient age was 57 years and 35% (218/615) of patients were ≥65 years, of which 17% (n=103) were 65 to <75; 14% (n=84) were 75 to <85, and 5% (n=31) were ≥85 years of age.
Danish: Patienternes median alder var 57 år og 35% (218/615) af patienterne var ≥65 år, hvoraf 17% (n = 103) var 65 til <75; 14% (n = 84) var 75 til <85, og 5% (n = 31) var ≥85 år.
English: The plasma protein binding of zanamivir is very low (less than 10%).
Danish: Plasmaproteinbindingen af zanamivir er meget lav (under 10 %).
English: The amount you are given is based on your age, body weight, and the results of your blood tests (to check how well your kidneys are working).
Danish: Den mængde, du får, er baseret på din alder, legemsvægt og resultatet af dine blodprøver (for at tjekke, hvor godt dine nyrer fungerer).
English: There were no significant differences in TTCR across treatment comparisons in the overall IPP or in two prespecified subgroups (Table 6).
Danish: Der var ingen signifikante forskelle i TTCR på tværs af behandlingssammenligningerne i den samlede IPP eller i de to foruddefinerede undergrupper (tabel 6).
English: These symptoms also occur in people with flu who are not being given Dectova.
Danish: Disse symptomer forekommer også hos mennesker med influenza, som ikke fik Dectova.
English: It is unlikely that you will be given too much, but if you think you have been given too much Dectova, tell your doctor or nurse immediately.
Danish: Det er ikke sandsynligt, at du får for meget, men hvis du mener, at du har fået for meget Dectova, skal du straks fortælle det til lægen eller sundhedspersonalet.
English: This is equivalent to 3.54% of the recommended maximum daily intake of sodium for an adult.
Danish: Dette svarer til 3,54 % af den anbefalede maksimale daglige indtagelse af natrium for en voksen.
English: This means that for scientific reasons it has not been possible to obtain complete information on this medicinal product.
Danish: Det betyder, at det af videnskabelige årsager ikke har været muligt at opnå fuldstændig dokumentation for lægemidlet.
English: Adults and children aged 6 months or more can be treated with Dectova.
Danish: Voksne og børn i alderen 6 måneder og derover kan behandles med Dectova.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2ºC to 8ºC, unless dilution has taken place in controlled and validated aseptic conditions.
Danish: Hvis det ikke anvendes straks, er opbevaringstider og -betingelser før anvendelse brugerens ansvar og bør ikke være længere end 24 timer ved 2 °C til 8 °C, medmindre fortynding har fundet sted under kontrollerede og validerede aseptiske forhold.
English: There is limited experience of overdose from administration of Dectova.
Danish: Der er begrænset erfaring med overdosering i forbindelse med administration af Dectova.
English: Dectova is used to treat severe flu (influenza virus infection).
Danish: Dectova bruges til at behandle alvorlig influenza (influenzavirusinfektion).
English: How to prepare the infusion for intravenous administration:
Danish: Sådan klargøres infusionsvæsken til intravenøs administration:
English: The most important serious adverse reaction was hepatocellular injury, observed in two patients (<1%).
Danish: Den vigtigste alvorlige bivirkning var hepatocellulær skade, der blev set hos to patienter (<1%).
English: Therefore, patients should be closely monitored for behavioural changes and the benefits and risks of continuing treatment should be carefully evaluated for each patient (see section 4.8).
Danish: Derfor skal patienterne monitoreres tæt med hensyn til adfærdsmæssige ændringer, og fordele og risici ved fortsat behandling skal vurderes nøje for den enkelte patient (se pkt.
English: • Calculate the required dose and volume of Dectova.
Danish: • Beregn den nødvendige dosis og volumen af Dectova.
English: Side effects where it is not known how likely they are to happen There isn't enough information to estimate how likely these side effects are:
Danish: Bivirkninger, hvor det ikke vides, hvor sandsynlige de er Der er ikke tilstrækkelig information til at fastslå hyppigheden af disse bivirkninger:
English: 6 months to < 6 years
Danish: 6 måneder til < 6 år
English: Patients were stratified at randomisation based on time from onset of symptoms to initiation of treatment (≤4 days and 5 to 6 days).
Danish: Patienterne blev stratificeret ved randomisering på basis af tiden fra symptomernes debut til behandlingsstart (≤ 4 dage og 5 til 6 dage).
English: Any unused solution should be discarded.
Danish: Eventuel ubrugt opløsning bør bortskaffes.
English: Overall, the safety profile in paediatric patients was similar to that observed in adults in the clinical studies.
Danish: Samlet set lignede sikkerhedsprofilen hos pædiatriske patienter, den man så hos voksne i de kliniske studier.
English: Contact your doctor or nurse straight away if you notice any of the following serious side effects:
Danish: Kontakt din læge eller sundhedspersonalet med det samme hvis du oplever følgende bivirkninger:
English: In adults with normal renal function, the elimination half-life is approximately 2-3 hours.
Danish: Hos voksne med normal nyrefunktion er elimineringshalveringstiden ca. 2-3 timer.
English: Limitations of the clinical data
Danish: De kliniske datas begrænsninger
English: • confused thinking
Danish: • uklare tanker
English: • liver damage (hepatocellular injury)
Danish: • leverskade (hepatocellulær skade)
English: If any hypersensitivity reaction occurs during infusion of Dectova, the infusion must be stopped immediately and appropriate management should be instituted.
Danish: Hvis der forekommer en overfølsomhedsreaktion under infusion af Dectova, skal infusionen stoppes straks, og passende behandling skal iværksættes.
English: Adverse reactions are listed by MedDRA system organ class.
Danish: Bivirkninger er anført efter MedDRA-systemorganklasse.
English: • The patient's influenza virus is known or suspected to be resistant to anti-influenza medicinal products other than zanamivir, and/or
Danish: • man ved eller mistænker, at patientens influenzavirus er resistent over for andre lægemidler mod influenza end zanamivir, og/eller
English: There was no evidence of interaction with oral oseltamivir in a clinical study.
Danish: Der var ingen evidens for interaktion med oralt oseltamivir i et klinisk studie.
English: Dectova contains zanamivir, which belongs to a group of medicines called antivirals.
Danish: Dectova indeholder zanamivir, som tilhører en gruppe lægemidler, der kaldes antivirale midler.
English: Adolescents, children and infants should receive a weight-based dose regimen for 5 to 10 days (Table 1).
Danish: Unge, børn og spædbørn skal have et vægtbaseret doseringsregime i 5 til 10 dage (tabel 1).
English: Dectova has not been shown to reduce the risk of bacterial complications associated with influenza infection.
Danish: Det er ikke påvist, at Dectova reducerer risikoen for bakterielle komplikationer forbundet med influenzainfektion.
English: The volume of distribution of zanamivir in adults is approximately 16 litres, which approximates the volume of extracellular water.
Danish: Zanamivirs fordelingsvolumen hos voksne er ca. 16 liter, som nærmer sig volumen af ekstracellulært vand.
English: A doctor or nurse will give you Dectova as an infusion (drip) into a vein.
Danish: En læge eller sygeplejerske giver dig Dectova som infusion i en blodåre (et drop).
English: Serious skin or allergic reactions
Danish: Alvorlige hudreaktioner eller allergiske reaktioner
English: Table 6: Statistical comparisons of TTCR between the 600 mg zanamivir group and each other group (IPP)
Danish: Tabel 6: Statistisk sammenligning af TTCR mellem 600 mg zanamivir-gruppen og hver af de andre grupper (IPP)
English: In the rat embryofoetal study, there was an increase in the incidence rates of a variety of minor skeletal and visceral alterations, most of which remained within the background rates of the historical occurrence in the strain studied.
Danish: I det embryoføtale studie med rotter var der en stigning i incidensraten for en række mindre skelet- og viscerale forandringer, hvoraf de fleste lå inden for baggrundsraterne for historisk forekomst i den undersøgte stamme.
English: • if you are allergic to zanamivir or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for zanamivir eller et af de øvrige indholdsstoffer i Dectova (angivet i punkt 6).
English: Do not use Dectova:
Danish: Brug ikke Dectova:
English: Serious skin and allergic reactions may occur with Dectova, but there isn't enough information to estimate how likely they are.
Danish: Alvorlige hudreaktioner og allergiske reaktioner kan muligvis forekomme ved brug af Dectova, men der er ikke oplysninger nok til at vurdere, hvor sandsynlige de er.
English: The neuraminidase substitution Q136K (A/H1N1 and A/H3N2), confers high level resistance to zanamivir but is selected during adaptation to cell culture and not during treatment.
Danish: Neuraminidasesubstitutionen Q136K (A/H1N1 og A/H3N2) giver høj resistens over for zanamivir, men selekteres under tilpasning til cellekultur og ikke under behandling.
English: So it is not known if Dectova played a part in causing them.
Danish: Så derfor vides det ikke, om Dectova var med til at fremkalde symptomerne.
English: Like all medicines, Dectova can cause side effects, although not everybody gets them.
Danish: Bivirkninger Dectova kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Neuropsychiatric events
Danish: Neuropsykiatriske hændelser
English: • If refrigerated, the infusion bag should be removed from the refrigerator and brought up to room temperature before use.
Danish: • Hvis infusionsposen opbevares på køl, skal den tages ud af køleskabet og bringes op på stuetemperatur før brug.
English: Common side effects These may affect up to 1 in 10 people
Danish: Almindelige bivirkninger Kan forekomme hos op til 1 ud af 10 personer
English: For patients receiving continuous renal replacement therapy, the dose should be selected using the appropriate CRRT clearance (CLCRRT in mL/min).
Danish: Hos patienter, der får kontinuerlig nyresubstitutionsterapi, skal dosis vælges på basis af den relevante CRRT-clearance (CLCRRT i ml/min).
English: Zanamivir is not an inducer of CYP1A2 and 2B6 and, although induction of CYP3A4 in vitro was observed at 50-fold higher than the clinically relevant concentrations, no interaction with CYP3A4 substrates is expected based on physiologically based pharmacokinetic modelling.
Danish: Zanamivir er ikke en inducer af CYP1A2 og 2B6, og selvom induktion af CYP3A4 in vitro blev observeret ved 50 gange højere end de klinisk relevante koncentrationer, forventes ingen interaktion med CYP3A4-substrater på baggrund af fysiologisk baseret farmakokinetisk modellering.
English: • clinical and virological activity of zanamivir compared to placebo in a human influenza challenge study;
Danish: • klinisk og virologisk aktivitet af zanamivir sammenlignet med placebo i et humant influenzaprovokationsstudie
English: It is unknown whether zanamivir is excreted in human milk.
Danish: Det er ukendt, om zanamivir udskilles i human mælk.
English: The safety and efficacy of Dectova in children aged under 6 months have not been established.
Danish: Dectovas sikkerhed og virkning hos børn i alderen under 6 måneder er ikke klarlagt.
English: Uncommon side effects These may affect up to 1 in 100 people
Danish: Ikke almindelige bivirkninger Kan forekomme hos op til 1 ud af 100 personer
English: Symptoms may include skin or throat swelling, difficulty breathing, blistering rash or peeling skin (see also ‘Serious skin or allergic reactions' in section 4).
Danish: Symptomer kan omfatte hævelse af huden eller i halsen, vejrtrækningsbesvær, udslæt med blærer eller afskallende hud (se også "Alvorlige hudreaktioner eller allergiske reaktioner' i punkt 4).
English: As experience is limited, the use of zanamivir in breast-feeding mothers should be considered only if the possible benefit to the mother is thought to outweigh any possible risk to the child.
Danish: Eftersom erfaringerne er begrænsede, bør brugen af zanamivir hos ammende mødre kun overvejes, hvis den mulige fordel for moderen menes at opveje enhver mulig risiko for barnet.
English: Human challenge study
Danish: Humant provokationsstudie
English: Serious hypersensitivity reactions
Danish: Alvorlige overfølsomhedsreaktioner
English: Dectova should not be administered simultaneously with other intravenous medicinal products or prepared in solutions containing glucose or other electrolytes (see section 6.6).
Danish: Dectova må ikke administreres samtidig med andre intravenøse lægemidler eller klargøres i opløsninger, der indeholder glucose eller andre elektrolytter (se pkt.
English: The most commonly reported adverse reactions considered possibly or probably related to Dectova are alanine aminotransferase increased (2%), aspartate aminotransferase increased (1%), hepatocellular injury (1%), diarrhoea (1%) and rash (1%).
Danish: De mest hyppige bivirkninger, der anses som muligvis eller sandsynligvis relateret til Dectova er forhøjet niveau af alaninaminotransferase (2%), forhøjet niveau af aspartataminotransferase (1%), hepatocellulær skade (1%), diarré (1%) og udslæt (1%).
English: There are limited data on zanamivir exposure during concomitant continuous renal replacement therapy and very limited data with dialysis.
Danish: Der er begrænsede data om zanamivireksponering under samtidig kontinuerlig nyresubstitutionsterapi og meget begrænsede data ved dialyse.
English: Table 7: Pharmacokinetic parameters in paediatric and adult subjects
Danish: Tabel 7: Farmakokinetiske parametre hos pædiatriske og voksne forsøgspersoner Aldersgruppe
English: Dectova has not been studied in patients with end-stage renal disease.
Danish: Dectova er ikke undersøgt hos patienter med terminal nyresygdom.
English: Zanamivir is eliminated unchanged in urine by glomerular filtration.
Danish: Zanamivir elimineres uomdannet i urinen via glomerulær filtrering.
English: For patients on intermittent haemodialysis or intermittent peritoneal dialysis, the dose should be given after completion of the dialysis session.
Danish: Hos patienter på intermitterende hæmodialyse eller intermitterende peritonealdialyse skal dosis gives efter afslutning af dialysesessionen.
English: • Other anti-viral medicinal products for treatment of influenza, including inhaled zanamivir, are not suitable for the individual patient.
Danish: • andre antivirale lægemidler til behandling af influenza ikke er velegnede til behandling af den enkelte patient, herunder inhaleret zanamivir.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, or toxicity to reproduction and development, with the exception of a rat embryofoetal development study (subcutaneous administration).
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, karcinogenicitet eller reproduktions- og udviklingstoksicitet, med undtagelse af et embryoføtalt udviklingsstudie med rotter (subkutan administration).
English: Pharmacokinetic studies in Thai, Chinese and Japanese healthy subjects did not identify any clinically relevant differences in the pharmacokinetics of zanamivir in these populations compared with Caucasians.
Danish: Farmakokinetiske undersøgelser hos raske thailandske, kinesiske og japanske forsøgspersoner påviste ikke nogen klinisk relevante forskelle i zanamivirs farmakokinetik hos disse populationer sammenlignet med kaukasiere.
English: As experience is limited, the use of Dectova in pregnancy should only be considered if the possible benefit to the patient is thought to outweigh any possible risk to the foetus.
Danish: Eftersom erfaringerne er begrænsede, bør brugen af Dectova under graviditet kun overvejes, hvis den mulige fordel for patienten menes at opveje enhver mulig risiko for fostret.
English:  6 years to < 18 years
Danish: ≥ 6 år til < 18 år