FrancophonIA/ELRC3.0 huggingface dataset:
English: Purevax Rabies is used to vaccinate cats from 12 weeks of age to protect against rabies infection.
Danish: Purevax Rabies anvendes til vaccination af katte fra 12-ugersalderen for at beskytte dem mod rabiesinfektion.
English: Other information about Purevax Rabies:
Danish: Andre oplysninger om Purevax Rabies:
English: The canarypox viruses do not spread or multiply in the cats but they do produce the glycoprotein G of the rabies virus.
Danish: Canarypox vira spreder eller formerer sig ikke i katte, men de danner glykoprotein G af rabiesvirusset.
English: The main measure of effectiveness was the ability of the vaccine to trigger immunity against rabies.
Danish: Behandlingens virkning blev hovedsagelig bedømt på vaccinens evne til at udløse immunitet over for rabies.
English: The vaccine strain vCP65 in Purevax Rabies is a ‘carrier' canarypox virus that has been given a gene that makes it able to produce part of a rabies virus called ‘glycoprotein G'.
Danish: Vaccinestammen vCP65 i Purevax Rabies er en ‘bærer' af canarypox virus, som har fået tilført et gen, der gør det i stand til at danne dele af et rabiesvirus kaldet ‘glykoprotein G'.
English: Purevax Rabies is a vaccine.
Danish: Purevax Rabies er en vaccine.
English: Purevax Rabies is a liquid suspension for injection.
Danish: Purevax Rabies er en injektionsvæske, suspension.
English: For a full list of the side-effects reported with Purevax Rabies, see the package leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved Purevax Rabies fremgår af indlægssedlen.
English: What is the risk associated with Purevax Rabies?
Danish: Hvilken risiko er der forbundet med Purevax Rabies?
English: When a cat is given the vaccine, the immune system recognises the rabies glycoprotein G as ‘foreign' and makes antibodies against it.
Danish: Når en kat vaccineres, opfatter immunsystemet rabies glykoprotein G som ‘fremmed' og danner antistoffer mod det. Immunsystemet vil derefter hurtigere kunne danne antistoffer, når det udsættes for rabies, og dette medvirker til at beskytte mod dødsfald som følge af rabiesinfektion.
English: Why has Purevax Rabies been approved?
Danish: Hvorfor blev Purevax Rabies godkendt?
English: How has Purevax Rabies been studied?
Danish: Hvordan blev Purevax Rabies undersøgt?
English: What is Purevax Rabies?
Danish: Hvad er Purevax Rabies?
English: What benefit has Purevax Rabies shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Purevax Rabies?
English: What is Purevax Rabies used for?
Danish: Hvad anvendes Purevax Rabies til?
English: How does Purevax Rabies work?
Danish: Hvordan virker Purevax Rabies?
English: Age < 50 years ≥ 50 years
Danish: Alder <50 år ≥50 år
English: Such changes may in part be linked to disease control and life style.
Danish: Sådanne forandringer kan delvist være forbundet med sygdomskontrol og livsstil.
English: Date of first authorisation: 21 September 2017
Danish: Dato for første markedsføringstilladelse: 21. september 2017
English: 3 years After first opening: 6 weeks
Danish: 3 år Efter første åbning: 6 uger.
English: The clinical relevance of this increase is unknown.
Danish: Den kliniske relevans af denne stigning kendes ikke.
English: Take Symtuza at around the same time each day.
Danish: Tag Symtuza på omtrent det samme tidspunkt hver dag.
English: your doctor may have to check your blood.
Danish: Din læge skal muligvis kontrollere dit blod.
English: Difference in Proportions
Danish: Forskel i proportioner
English: These events are often transitory.
Danish: Disse bivirkninger er ofte forbigående.
English: Darunavir Results from a mass balance study with [
Danish: Darunavir Resultaterne fra et massebalancestudie med [
English: Anti-HIV medicines may make you feel better.
Danish: Anti-hiv-lægemidler kan få dig til at føle dig bedre.
English: These interactions are described in the interaction table below.
Danish: Disse interaktioner er beskrevet i interaktionstabellen nedenfor.
English: In some cases dosage of other medicines might need to be changed.
Danish: I nogle tilfælde kan det være nødvendigt at ændre dosis af andre lægemidler.
English: Keep the tablet bottle with you so that you can show what you have taken.
Danish: Tag tabletbeholderen med dig, så du kan vise, hvad det er du har taget.
English: The disease may then become harder to treat.
Danish: Det kan gøre sygdommen sværere at behandle.
English: You must eat a meal or a snack within 30 minutes before taking your Symtuza.
Danish: Du skal spise et måltid eller en snack, inden for 30 minutter før du tager Symtuza.
English: Precautions to prevent transmission should be taken in accordance with national guidelines.
Danish: Der skal træffes foranstaltninger med henblik på at forebygge overførsel i overensstemmelse med nationale retningslinjer.
English: • severe swelling of the skin and other tissues (most often the lips or the eyes)
Danish: • svær hævelse af huden og andre væv (oftest læberne eller øjnene)
English: Primary PI/DRV
Danish: Primær PI/DRV
English: In more than half of the reported cases, treatment with HIV PIs was continued or reintroduced if treatment had been discontinued.
Danish: I mere end halvdelen af de rapporterede tilfælde fortsatte behandlingen med hiv-PI, eller behandlingen blev genoptaget, hvis den havde været afbrudt.
English: When co-administration is required, the daily dose of itraconazole should not exceed 200 mg.
Danish: Hvis co-administration er nødvendig, må den daglige dosis af itraconazol ikke overskride 200 mg.
English: Your doctor will consider if Symtuza is the right medicine for you.
Danish: Din læge vil overveje, om Symtuza er det rigtige lægemiddel til dig.
English: Total Phase 3
Danish: I alt fase 3
English: If you notice any of these symptoms tell your doctor.
Danish: Hvis du bemærker nogen af disse symptomer, skal du fortælle det til din læge.
English: Consideration should be given to official guidance on the appropriate treatment of tuberculosis in HIV infected patients.
Danish: Der skal tages højde for de officielle retningslinjer for passende behandling af tuberkulose hos hiv-inficerede patienter.
English: EU/1/17/1225/001- 30 film-coated tablets EU/1/17/1225/002- 90 film-coated tablets (3 x 30)
Danish: EU/1/17/1225/001 - 30 filmovertrukne tabletter EU/1/17/1225/002 - 90 filmovertrukne tabletter (3 x 30)
English: Contact your doctor or nearest emergency department immediately for advice.
Danish: Kontakt straks din læge eller nærmeste akutmodtagelse for at få råd.
English: 90 film-coated tablets (3 bottles containing 30 tablets each) The bottles are not to be distributed individually.
Danish: 90 filmovertrukne tabletter (3 beholdere der indeholder 30 tabletter hver) Beholderne må ikke distribueres individuelt.
English: Table 1: Interactions between the individual components of Symtuza and other medicinal products
Danish: Tabel 1: Interaktioner mellem de individuelle komponenter i Symtuza og andre lægemidler
English: Protocol Defined Rebound Rate (95% CI)
Danish: Protokoldefineret reboundrate (95 % CI)
English: You must take Symtuza every day and always with food.
Danish: Du skal tage Symtuza hver dag og altid sammen med mad.
English: This recommendation is different from ritonavir-boosted darunavir.
Danish: Denne anbefaling er forskellig fra ritonavir-boostet darunavir.
English: Pregnant or breast-feeding mothers should not take Symtuza.
Danish: Gravide eller ammende mødre bør ikke tage Symtuza.
English: The tablet can be taken with a drink such as water, milk or any nutritional drink.
Danish: Tabletten kan tages med væske som f.eks. vand, mælk eller enhver næringsrig drik.
English: They either switched to Symtuza (N = 763) or continued their treatment regimen (N = 378) (randomised 2:1).
Danish: Enten skiftede de til Symtuza (N = 763) eller de fortsatte deres behandlingsregime (N = 378) (randomiseret 2:1).
English: Further dosage reduction of rifabutin has not been studied.
Danish: Yderligere reduktion af rifabutindosis er ikke undersøgt.
English: If you have kidney or liver problems see section ‘Do not combine
Danish: Hvis du har nyre- eller leverproblemer, se afsnittet 'Du må ikke tage
English: Two-sided Exact Clopper-Pearson 95% CI
Danish: Tosidet eksakt Clopper-Pearson 95 % CI
English: • The tablet should not be crushed, but swallowed whole.
Danish: • Tabletten må ikke knuses, den skal synkes hel.
English: Cumulative Protocol-Defined Virologic Rebound a, %
Danish: Akkumuleret protokoldefineret virologisk rebound a, %
English: Therefore, always tell your doctor if you take other anti-HIV medicines and follow your doctor's instruction carefully on which medicines can be combined.
Danish: Du skal derfor altid fortælle din læge, hvis du tager anden hiv-medicin, og følge din læges anvisninger nøje med hensyn til, hvilke lægemidler der kan tages sammen.
English: Co-administration of other medicinal products
Danish: Co-administration af andre lægemidler
English: • if you are allergic to sulphonamides (e.g. used to treat certain infections).
Danish: • Hvis du er allergisk over for sulfonamider (som f.eks. anvendes til behandling af visse infektioner).
English: In vitro selection of darunavir-resistant virus from wild type HIV-1 was lengthy (> 3 years).
Danish: In vitro-selektion af darunavir-resistent virus fra vildtype hiv-1 tog lang tid (> 3 år).
English: Week 48 window: Day 295 - Day 378; Week 96 window: Day 631 - Day 714
Danish: Uge 48-vindue: Dag 295 - dag 378; Uge 96-vindue: Dag 631 - dag 714
English: Do not operate machines or drive if you feel dizzy after taking Symtuza.
Danish: Du må ikke betjene maskiner eller køre bil, hvis du føler dig svimmel efter du har taget Symtuza.
English: Each bottle contains 30 tablets.
Danish: Hver beholder indeholder 30 tabletter.
English: It is recommended that women with HIV do not breast-feed their infants because of the possibility of the baby becoming infected with HIV through breast milk and because the medicine may affect the baby.
Danish: Det anbefales at kvinder med hiv ikke ammer deres børn, fordi der er risiko for, at barnet bliver smittet med hiv via mælken, og fordi lægemidlet kan påvirke barnet.
English: This is very important because the amount of virus may start to increase if the medicine is stopped for even a short time.
Danish: Dette er meget vigtigt, da virusmængden igen kan begynde at stige, hvis du holder op med at tage medicinen, selv i kort tid.
English: Discuss with your physician the precautions needed to avoid infecting other people.
Danish: Tal med lægen om, hvilke forholdsregler der er nødvendige for at undgå at smitte andre.
English: Alternative anticonvulsants should be considered.
Danish: Alternative antiepileptika skal overvejes.
English: ART-experienced patients
Danish: ART-erfarne patienter
English: Symtuza is not for use in children younger than 12 years, or weighing less than 40 kg, as it has not been studied in children under 12 years.
Danish: Symtuza er ikke beregnet til brug hos børn under 12 år eller som vejer mindre end 40 kg, da det ikke er blevet undersøgt hos børn under 12 år.
English: At Week 36 M184M/I/V observed, conferring resistance to FTC.
Danish: Ved uge 36 blev der observeret M184M/I/V, som bibringer resistens over for FTC.
English: Tell your doctor immediately, if any of these apply to you.
Danish: Fortæl det straks til lægen, hvis noget af følgende gælder for dig.
English: Infrequently a rash may become severe or potentially life-threatening.
Danish: Sjældent kan et udslæt blive alvorligt eller muligvis livstruende.
English: It is believed that these symptoms are due to an improvement in the body's immune response, enabling the body to fight infections that may have been present with no obvious symptoms.
Danish: Det menes, at disse symptomer skyldes en forbedring af kroppens immunforsvar, der gør det muligt for kroppen at bekæmpe infektioner, som kan have været til stede uden nogle tydelige symptomer.
English: It should be kept in mind that the twice weekly dosage 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 skal tages i betragtning, at en dosis på 150 mg to gange ugentligt muligvis ikke giver en optimal eksponering for rifabutin, hvilket kan medføre risiko for rifabutinresistens og behandlingssvigt.
English: For lipids, there is in some cases evidence for a treatment effect, while for weight gain there is no strong evidence relating this to any particular treatment.
Danish: For lipider er der i visse tilfælde fundet evidens for en behandlingseffekt, mens der for vægtøgning ikke er stærke beviser for dette i forhold til en bestemt behandling.
English: The safety and efficacy of Symtuza in children aged 3-11 years, or weighing < 40 kg, have not yet been established.
Danish: Symtuzas sikkerhed og virkning hos børn i alderen 3-11 år, eller som vejer < 40 kg, er endnu ikke klarlagt.
English: While effective viral suppression with antiretroviral therapy (ART) has been proven to substantially reduce the risk of sexual transmission, a residual risk cannot be excluded.
Danish: Selvom effektiv viral suppression med antiretroviral behandling (ART) er påvist at nedsætte risikoen for seksuel overførsel væsentligt, kan en residual risiko ikke udelukkes.
English: A [
Danish: Et [
English: Symtuza with any of the following medicines'.
Danish: Symtuza sammen med følgende lægemidler'.
English: Voriconazole should only be taken after medical evaluation.
Danish: Voriconazol må kun tages efter en lægeundersøgelse.
English: Even when you feel better, do not stop taking Symtuza.
Danish: Selvom du har det bedre, må du ikke holde op med at tage Symtuza.
English: Adverse reactions are listed by system organ class (SOC) and frequency category in Table 2.
Danish: Bivirkningerne er opstillet efter systemorganklasse (SOC) og hyppighedskategori i tabel 2.
English: Your doctor will advise you how to deal with your symptoms or whether Symtuza must be stopped.
Danish: Din læge vil rådgive dig om, hvordan du skal håndtere dine symptomer, eller om behandling med Symtuza skal stoppes.
English: Frequency categories are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000) and not known (frequency cannot be estimated from the available data)
Danish: Hyppighedskategorierne defineres som følger: 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 ikke kendt (hyppighed kan ikke estimeres ud fra forhåndenværende data)
English: Postpartum (6-12 weeks) N = 6
Danish: Post partum (6-12 uger) (n = 6)
English: Voriconazole should not be combined with Symtuza unless an assessment of the benefit/risk ratio justifies the use of voriconazole.
Danish: Voriconazol bør ikke kombineres med Symtuza, medmindre en risk/benefit-vurdering retfærdiggør brugen af voriconazol.
English: These findings do not affect current national recommendations to use antiretroviral therapy in pregnant women to prevent vertical transmission of HIV.
Danish: Disse fund påvirker ikke gældende nationale anbefalinger vedrørende brugen af antiretroviral behandling hos gravide kvinder med henblik på at forebygge vertikal overførsel af hiv.
English: If the combination is needed, the recommended dose of rifabutin is 150 mg 3 times per week on set days (for example Monday-Wednesday-Friday).
Danish: Hvis kombination er nødvendig, er den anbefalede rifabutindosis 150 mg 3 gange om ugen på faste dage (for eksempel mandag-onsdag-fredag).
English: Reasons
Danish: Årsager
English: People taking Symtuza may still develop infections or other illnesses associated with HIV infection.
Danish: Personer, der tager Symtuza, kan stadig udvikle infektioner eller andre sygdomme forbundet med hiv-infektion.
English: These are mentioned above under the heading ‘Do not combine Symtuza with any of the following medicines:'
Danish: Disse er nævnt ovenfor under overskriften 'Du må ikke tage Symtuza sammen med følgende lægemidler:'
English: You may require blood tests for several months after stopping treatment with Symtuza.
Danish: Det kan være nødvendigt at få taget blodprøver i flere måneder efter ophør med behandlingen med Symtuza.
English: Total cholesterol (mmol/L) LDL cholesterol (mmol/L) HDL cholesterol (mmol/L) Triglycerides (mmol/L)
Danish: Total kolesterol (mmol/l) LDL-kolesterol (mmol/l) HDL-kolesterol (mmol/l) Triglycerider (mmol/l)
English: The absolute bioavailability of the emtricitabine 200 mg capsule was 93%.
Danish: Den absolutte biotilgængelighed for emtricitabin 200 mg, kapsel var 93 %.
English: Dose adjustment for midazolam should be considered, especially if more than a single dose of midazolam is administered.
Danish: Justering af midazolamdosis bør overvejes, især ved administration af mere end en enkelt dosis midazolam.
English: Tell your healthcare provider about all medicines that you are taking.
Danish: Fortæl din læge om alle lægemidler, du tager.
English: If you belong to this age group, please discuss with your doctor if you can use Symtuza.
Danish: Hvis du tilhører denne aldersgruppe, skal du spørge din læge, om du kan tage Symtuza.
English: Treatment of overdose with Symtuza 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 Symtuza består af generelle understøttende foranstaltninger, herunder overvågning af vitale tegn og observation af patientens kliniske tilstand.
English: Appropriate laboratory testing should be conducted prior to initiating therapy with Symtuza and patients should be monitored during treatment.
Danish: Relevante laboratorieundersøgelser skal udføres før behandling med Symtuza påbegyndes, og patienterne skal overvåges under behandlingen.
English: Other severe side effects, seen up to 1 patient in 10, were diabetes, increased blood fat levels and symptoms of infection.
Danish: Andre alvorlige bivirkninger, der er set hos op til 1 ud af 10 patienter, var diabetes, forhøjet indhold af fedtstoffer i blodet og symptomer på infektion.
English: These EC50 values are well below the 50% cellular toxicity concentration range of 87 µM to > 100 µM.
Danish: Disse EC50-værdier ligger langt under 50 % af koncentrationsområdet for cellulær toksicitet på 87 μM til > 100 μM.
English: Inflammation of the pancreas (pancreatitis) has been reported in up to 1 patient in 100.
Danish: Betændelse i bugspytkirtlen (pancreatitis) har været indberettet hos op til 1 ud af 100 patienter.
English: • if you have diabetes.
Danish: • Hvis du har sukkersyge (diabetes).
English: Based on animal studies, no effect on reproduction or fertility is expected with Symtuza.
Danish: Baseret på dyrestudier forventes der ingen effekt på reproduktion eller fertilitet med Symtuza.
English: The tablet should not be crushed.
Danish: Tabletten må ikke knuses.
English: Tell your doctor immediately about new or unusual symptoms after you stop treatment, particularly symptoms you associate with hepatitis B infection.
Danish: Fortæl det straks til din læge, hvis du bemærker nye eller usædvanlige symptomer efter behandlingens ophør, især hvis det drejer sig om symptomer, som du normalt ville forbinde med hepatitis B-infektion.
English: Cobicistat Following oral administration of [
Danish: Cobicistat Efter oral administration af [
English: Your doctor will evaluate which cholesterol lowering regimen is best for your specific situation.
Danish: Din læge vil vurdere, hvilken kolesterolsænkende behandling, der egner sig bedst i din specifikke situation.
English: It is recommended that the lowest possible dose of digoxin should initially be given to patients on Symtuza.
Danish: Det anbefales initialt at give den lavest mulige dosis digoxin til patienter i behandling med Symtuza.
English: Although most rashes are mild and disappear after a while as treatment is continued, a rash can occasionally be severe or potentially life-threatening.
Danish: Selv om de fleste udslæt er milde og forsvinder efter et stykke tid ved fortsat behandling, kan et udslæt til tider være kraftigt og eventuelt livstruende.
English: to help you sleep and/or relieve anxiety
Danish: som sovemiddel og/eller til at afhjælpe angst
English: • if you have had problems with your liver, including hepatitis B or C infection.
Danish: • Hvis du har haft problemer med leveren, herunder hepatitis B- eller C-infektion.
English: Emerging resistance in the Symtuza groups is shown in Table 4.
Danish: Ny resistens i Symtuza-grupperne er vist i tabel 4.
English: Do not combine Symtuza with any of the following medicines If you are taking any of these, ask your doctor about switching to another medicine.
Danish: Du må ikke tage Symtuza sammen med følgende lægemidler Hvis du tager et af disse lægemidler, skal du tale med din læge om at skifte til anden medicin.
English: If you have chronic hepatitis B or C infection, your doctor should check your blood tests more often because you have an increased chance of developing liver problems.
Danish: Hvis du har kronisk hepatitis B eller C, skal din læge kontrollere dine blodprøver oftere, fordi du har en øget risiko for at få leverproblemer.
English: The digoxin dose should be carefully titrated to obtain the desired clinical effect while assessing the overall clinical state of the subject.
Danish: Digoxindosis skal titreres forsigtigt for at opnå den ønskede kliniske effekt samtidig med, at patientens generelle kliniske tilstand vurderes.
English: Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to CART.
Danish: Der er rapporteret tilfælde af osteonekrose, især hos patienter med generelt anerkendte risikofaktorer, fremskreden hiv-sygdom eller langvarig eksponering for CART.
English: Interaction trials with the components of Symtuza have only been performed in adults.
Danish: Interaktionsstudier med komponenterne i Symtuza er kun udført hos voksne.
English: However, unbound darunavir concentrations were approximately 55% (Child-Pugh Class A) and 100% (Child-Pugh Class B) higher, respectively.
Danish: Dog var koncentrationen af ubundet darunavir henholdsvis ca. 55 % (Child-Pugh klasse A) og 100 % (Child-Pugh klasse B) højere.
English: Avanafil to treat erectile dysfunction
Danish: Avanafil til behandling af erektil dysfunktion
English: The frequency of this is unknown (see section 4.4).
Danish: Hyppigheden af dette er ikke kendt (se pkt.
English: OESTROGEN-BASED CONTRACEPTIVES Drospirenone Ethinylestradiol (3 mg/0.02 mg once daily)
Danish: ØSTROGENBASEREDE KONTRACEPTIVA Drospirenon ethinylestradiol (3 mg/0,02 mg en gang dagligt)
English: • Push the plastic screw cap down while turning it counter clockwise.
Danish: • Tryk plastskruelåget nedad, samtidig med at det drejes mod uret.
English: IMMUNOSUPPRESSANTS Ciclosporin
Danish: IMMUNSUPPRESIVA Ciclosporin
English: Contact your doctor if you are uncertain about what to do if you miss a dose or vomit.
Danish: Kontakt lægen, hvis du er usikker på, hvad du skal gøre, hvis du har glemt en dosis eller har kastet op.
English: Renal excretion of intact tenofovir alafenamide is a minor pathway with less than 1% of the dose eliminated in urine.
Danish: Renal udskillelse af intakt tenofoviralafenamid er en mindre metaboliseringsvej med mindre end 1 % af dosen elimineret i urinen.
English: If you have both HIV infection and hepatitis B, it is very important not to stop taking Symtuza without talking to your doctor first.
Danish: Hvis du har både hiv-infektion og hepatitis B, er det meget vigtigt, at du ikke holder op med at tage Symtuza uden først at tale med lægen.
English: In juvenile rats receiving darunavir up to days 23-26 (equivalent to less than 2 years of age in humans), increased mortality was observed with convulsions in some animals.
Danish: Hos unge rotter, der fik darunavir indtil dag 23-26 (svarende til en alder på under 2 år hos mennesker), blev der observeret øget mortalitet med kramper hos nogle dyr.
English: Non-black
Danish: Ikke-sort
English: Symtuza has only been used in limited numbers of patients 65 years or older.
Danish: Symtuza har kun været anvendt til et begrænset antal patienter over 65 år.