FrancophonIA/ELRC3.0 huggingface dataset:
English: Discuss with your physician the precautions needed to avoid infecting other people.
Danish: Tal med din læge om de nødvendige forholdsregler, der skal tages for at undgå at smitte andre personer.
English: Elderly: There is no experience in patients > 65 years old.
Danish: Ældre: Der er ingen erfaringer hos patienter > 65 år.
English: Make sure you never touch the needle with your fingers or anything else.
Danish: Det er vigtigt, at du aldrig rører nålen med fingrene eller med noget andet.
English: Animal studies do not indicate harmful effects with respect to foetal development.
Danish: Dyrestudier viser ikke skadelige virkninger på fosterudviklingen.
English: Fuzeon with food and drink
Danish: Tag af Fuzeon sammen med mad og drikke
English: Treatment Difference
Danish: Behandlingsforskel
English: These signs do not definitely mean you are allergic to this medicine.
Danish: Disse symptomer betyder ikke med sikkerhed, at du er allergisk over for medicinen.
English: Signs of previous infections
Danish: Tegn på tidligere infektion
English: • Then pull out the water again.
Danish: • Herefter kan du trække vandet ind igen.
English: In clinical trials the dosage regimen in Table 1 below was used:
Danish: I kliniske forsøg blev doseringsregimet, som er anvist i tabel 1 nedenfor, anvendt:
English: • The other ingredients are:
Danish: • Øvrige indholdsstoffer:
English: It is believed that these symptoms are due to a recovery of the body's immune system.
Danish: Det antages, at disse symptomer skyldes en bedring af kroppens immunforsvar.
English: Infections at the injection site (including abscess and cellulitis) occurred in 1.5% of patients.
Danish: Infektioner ved injektionsstedet (inklusive absces og cellulitis) opstod hos 1,5 % af patienterne.
English: Reactions may be worse when injections are repeated in the same place on the body.
Danish: Reaktionerne kan forværres, hvis indsprøjtningerne gentagesdet samme sted.
English: • If you forget to use a dose, use it as soon as you remember it.
Danish: • Hvis du glemmer en dosis, skal du tage den, så snart du kommer i tanke om det.
English: Chemical and physical in-use stability has been demonstrated for 48 hours at 5°C when protected from light.
Danish: Der er vist kemisk og fysisk stabilitet i 48 timer ved 5 °C, når det beskyttes mod lys.
English: The resistance to influenza and streptococcal infection in rats was only weakly compromised.
Danish: Resistensen over for influenza- og streptokokinfektion hos rotterne blev kun svagt kompromitteret.
English: The substitutions observed in decreasing frequency were at aa positions 38, 43, 36, 40, 42 and 45.
Danish: De observerede substitutioner, nævnt efter faldende hyppighed, var i aminosyrepositionerne 38, 43, 36, 40, 42 og 45.
English: If this happens, your blood levels of virus may begin to rise.
Danish: Hvis det sker, vil antallet af virus i blodet begynde at stige.
English: Erythema c c
Danish: Erytem c c
English: - You will hear a click.
Danish: • du vil kunne høre et klik.
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Danish: Bivirkninger Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: If you need help, ask your partner, a friend, or a family member.
Danish: Hvis du har brug for hjælp, kan du spørge din partner, en ven eller et familiemedlem.
English: • Do not take a double dose to make up for a forgotten dose.
Danish: • Tag aldrig dobbelt dosis for at indhente en glemt dosis.
English: There is no specific antidote for overdose with enfuvirtide.
Danish: Der er ingen specifik antidot for overdosering med enfuvirtid.
English: Patients had prior exposure to a median of 12 antiretrovirals for a median of 7 years.
Danish: Patienterne var tidligere eksponeret for mediant 12 antiretrovirale lægemidler i mediant 7 år.
English: Enfuvirtide should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Danish: Enfuvirtid må kun anvendes under graviditet, hvis den potentielle gevinst berettiger den potentielle risiko for fostret.
English: It is bound predominantly to albumin and to a lower extent to α-1 acid glycoprotein.
Danish: Det bindes fortrinsvis til albumin og i mindre udstrækning til α-1 glykoproteinsyre.
English: This leaflet is available in all EU/EEA languages on the European Medicines Agency website.
Danish: Denne indlægsseddel findes på alle EU-/EØS-sprog på Det Europæiske Lægemiddelagenturs hjemmeside.
English: HIV attacks cells in your blood called CD4 or T-cells.
Danish: Hiv angriber de celler i blodet, der kaldes CD4 eller T-celler.
English: Pregnancy: There are no adequate and well-controlled studies in pregnant women.
Danish: Graviditet: Der foreligger ikke tilstrækkelige data eller vel-kontrollerede studier hos gravide kvinder.
English: Nodules and cysts e e
Danish: Knuder og cyster e e
English: • Let the water flow slowly down the inside of the vial.
Danish: • Lad vandet flyde langsomt ned af indersiden af hætteglasset.
English: You should not use Fuzeon unless specifically told to by your doctor.
Danish: Du må ikke bruge Fuzeon, medmindre lægen specifikt har ordineret det til dig.
English: However, these changes are not clinically significant and no dose adjustment is required.
Danish: Ændringerne er dog uden klinisk betydning, og dosisjustering er ikke nødvendig.
English: Push the needle into the skin at a 45-degree angle.
Danish: Stik nålen i huden i en vinkel på 45 grader.
English: Anxiety, nightmare, irritability
Danish: Angst, mareridt, irritabilitet
English: Powder 4 years
Danish: Pulver 4 år
English: Solvent This medicinal product does not require any special storage conditions.
Danish: Solvens Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen.
English: Denominator for non-switch patients: N=112.
Danish: Nævner for patienter som ikke skifter: N=112.
English: • If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Danish: • Hvis du er gravid, 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: Stop using Fuzeon and see a doctor straight away, if you notice any of the following serious side effects - you may need urgent medical treatment:
Danish: Stop med at tage Fuzeon og kontakt straks lægen, hvis du bemærker én eller flere af følgende alvorlige bivirkninger - du har måske behov for akut behandling:
English: See further instructions on how to use Fuzeon at the end of this leaflet (see Section 7).
Danish: Du kan finde yderligere vejledning i anvendelsen af Fuzeon i slutningen af denne indlægsseddel (se afsnit 7).
English: • blood in the urine
Danish: • blod i urinen
English: This metabolite is detected in human plasma following administration of enfuvirtide, with an AUC ranging from 2.4 to 15% of the enfuvirtide AUC.
Danish: Denne metabolit findes i humant plasma efter administration af enfuvirtid, og den har en AUC, som spænder fra 2,4 til 15 % af enfuvirtids AUC.
English: While effective viral suppression with antiretroviral therapy 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 har vist en væsentlig nedsættelse af risikoen for seksuel transmission kan en residualrisiko ikke udelukkes.
English: After reconstitution: Store in a refrigerator (2°C - 8°C).
Danish: Efter rekonstituering: Opbevares i køleskab (2 °C - 8 °C).
English: fGrade 3= refractory to topical treatment or requiring oral or parenteral treatment; Grade 4= not defined.
Danish: fGrad 3 = refraktorisk over for topikal behandling eller med behov for oral eller parenteral behandling; Grad 4 = ikke defineret.
English: Adverse reactions are listed according to MedDRA system organ class and frequency category.
Danish: Bivirkninger er angivet i overensstemmelse med MedDRA-systemets organklassificering og hyppighedskategorier.
English: Step A: Getting Started
Danish: Trin A: Sådan starter du
English: If you touch them, make sure you clean them again.
Danish: Hvis du kommer til at røre dem, er det vigtigt, at du rengør dem igen.
English: 4 It is important to check the liquid for bits (particles).
Danish: 4 Det er vigtigt at undersøge væsken for partikler.
English: For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du vil have yderligere oplysninger om dette lægemiddel, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: • The HIV virus in your blood may eventually become resistant to Fuzeon.
Danish: • Hiv-virussen i blodet kan blive resistent over for Fuzeon.
English: Pharmacotherapeutic group: Other antivirals, ATC code: J05AX07
Danish: Farmakoterapeutisk klassifikation: Andre antivirale lægemidler, ATC kode: J05AX07
English: Fuzeon +Optimised background a
Danish: Fuzeon +optimeret baggrunds (OB)behandling a
English: When to have someone to help you
Danish: Hvis du har brug for hjælp
English: In an Early Access Program study, one patient was administered 180 mg of Fuzeon as a single dose on one occasion.
Danish: I et Early Access Program-studie fik en patient administreret 180 mg Fuzeon som enkeltdosis ved en enkelt lejlighed.
English: The frequency of this is unknown (see section 4.4).
Danish: Hyppigheden heraf er ukendt (se pkt.
English: Percentages based on safety population Fuzeon+background (N=663) and background (N=334).
Danish: Procenter baseret på sikkerhedspopulationen Fuzeon+baggrundsbehandling (N=663) og baggrundsbehandling (N=334).
English: Treatment of overdose should consist of general supportive measures.
Danish: Behandling af en overdosis består af almindelig understøttende behandling.
English: 995 patients comprised the intent-to-treat population.
Danish: Intent-to-treat-populationen omfattede 995 patienter.
English: • This medicine has been prescribed for you only.
Danish: • Lægen har ordineret dette lægemiddel til dig personligt.
English: Tip: Your doctor or nurse may suggest different injection techniques that will work best for you.
Danish: Tip: Måske kan lægen eller sygeplejersken foreslå en anden måde at give indsprøjtningen på, som passer bedre til dig.
English: Make sure none of the items in your kit have been opened before use.
Danish: Tjek, at ingen af tingene i pakningen har været åbnet,
English: • pain and feeling numb in hands, feet or legs.
Danish: • smerte og følelsesløshed i hænder, fødder eller ben
English: Step E: Disposing of used supplies
Danish: Trin E: Bortskaffelse af brugt materialer
English: This pack provides you with everything you need to prepare and take your Fuzeon for 30 days of injections.
Danish: Pakningen indeholder alt, hvad du har brug for til at tilberede og tage din Fuzeon-injektion i 30 dage.
English: These patients did not experience any adverse reactions that were not seen with the recommended dose.
Danish: Disse patienter oplevede ingen bivirkninger, som ikke også var set efter den anbefalede dosis.
English: Children ≥ 6 years and adolescents: The experience in children is limited (see section 5.2).
Danish: Børn over ≥ 6 år og unge: Erfaringen med børn er begrænset (se pkt.
English: Before the solution is withdrawn for administration, the patient should inspect the vial visually to ensure that the contents are fully in solution, and that the solution is clear and without bubbles or particulate matter.
Danish: Før opløsningen trækkes op til administration, skal hætteglas undersøges visuelt for at sikre, at indholdet er fuldstændig opløst, og at opløsningen er klar og uden bobler eller partikler.
English: Safety results are expressed as the number of patients with an adverse reaction per 100 patientyears of exposure (except for injection site reactions).
Danish: Sikkerhedsresultaterne er angivet som antal patienter med en bivirkning pr. 100 patienteksponeringsår (bortset fra reaktioner på injektionsstedet).
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Sundhedsstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indberette bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: • The active substance is enfuvirtide.
Danish: • Aktivt stof: Enfuvirtid.
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis carinii pneumonia.
Danish: Relevante eksempler er cytomegalovirus retinitis, generaliserede og/eller fokale mycobakterielle infektioner og pneumocystis carinii pneumoni.
English: • Do not inject to a place where there is still a reaction from an earlier dose.
Danish: • Vælg ikke et sted, hvor du kan se, at der stadig er en reaktion fra en tidligere indsprøjtning.
English: How much to use
Danish: Så meget skal du tage
English: In in vitro studies, enfuvirtide was not displaced from its binding sites by other medicinal products, nor did enfuvirtide displace other medicinal products from their binding sites.
Danish: I in vitro-studier blev enfuvirtid ikke erstattet fra sine bindingssteder af andre lægemidler, og enfuvirtid erstattede heller ikke andre lægemidler fra deres bindingssteder.
English: If you notice any symptoms of infection, please inform your doctor immediately.
Danish: Hvis du bemærker nogen som helst symptomer på infektion, skal du omgående informere din læge.
English: The signs and symptoms generally lasted equal to or less than 7 days.
Danish: Kliniske tegn og symptomer varede almindeligvis i højst 7 dage.
English: Fuzeon is not recommended for use in children below age 6 due to insufficient data on safety and efficacy (see section 5.2).
Danish: Fuzeon frarådes til børn under 6 år på grund af utilstrækkelige data om sikkerhed og effekt (se pkt.
English: Injection site reactions (ISRs) were the most frequently reported adverse reaction and occurred in 98% of the patients (Table 3).
Danish: Reaktioner på injektionsstedet var de hyppigst indberettede bivirkninger, og disse opstod hos 98 % af patienterne (Tabel 3).
English: Patients should be informed that Fuzeon is not a cure for HIV-1 infection.
Danish: Patienter skal informeres om, at Fuzeon ikke kan helbrede en hiv-1-infektion.
English: In HIV patients, enfuvirtide levels in the cerebrospinal fluid have been reported to be negligible.
Danish: Hos hiv-patienter er enfuvirtid-niveauer i cerebrospinalvæsken blevet rapporteret som ubetydelige.
English: HIV RNA >1 log below Baseline**
Danish: Hiv-RNA > 1 log under baseline**
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal
Danish: • Periodiske, opdaterede sikkerhedsindberetninger (PSUR´er) Indehaveren af markedsføringstilladelsen skal fremsende PSUR for dette lægemiddel i overensstemmelse med kravene på listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og offentliggjort på den europæiske webportal for lægemidler.
English: The injection should be given at a site different from the preceding injection site and where there is no current injection site reaction.
Danish: Injektionen skal gives på et andet sted end den foregående injektion og på et sted, hvor der ikke er tegn på en injektionsreaktion.
English: Please be aware that the vial contains more liquid than you need (2 ml); you only have to pull out 1.1 ml to prepare your injection properly.
Danish: Vær opmærksom på, at hætteglasset indeholder mere væske, end du har brug for (2 ml); du skal kun bruge 1,1 ml for at tilberede medicinen korrekt.
English: If you use more Fuzeon than you should, talk to a doctor or go to a hospital straight away.
Danish: Hvis du kommer til at tage mere Fuzeon, end du skal, skal du straks kontakte lægen eller tage på hospitalet.
English: In case a Fuzeon dose is missed, patients should be instructed to administer the dose as soon as possible.
Danish: Hvis patienten har glemt at tage en dosis Fuzeon, skal patienten informeres om at administrere dosis så hurtigt som muligt.
English: Peripheral neuropathy Hypoaesthesia, disturbance in attention, tremor
Danish: Perifer neuropati Hypæstesi, opmærksomhedsforstyrrelser, tremor
English: CD4+ cell count Change from baseline (cells/mm3)#
Danish: CD4+ celletal Ændring fra baseline (celler/mm3)#
English: The most frequently reported events were injection site reactions, diarrhoea and nausea.
Danish: De hyppigst indberettede bivirkninger var reaktioner ved injektionsstedet, diarré og kvalme.
English: ** M-H test: Discontinuations or virological failure considered as failures.
Danish: ** M-H-test: Behandlingsstop eller virologisk svigt betragtes som behandlingssvigt.
English: As with other antiretrovirals, enfuvirtide should optimally be combined with other antiretrovirals to which the patient's virus is sensitive (see section 5.1).
Danish: Som ved andre antiretrovirale midler bør enfuvirtid optimalt kombineres med andre antiretrovirale midler, som patientens virus er følsom overfor (se pkt.
English: Fuzeon+OB regimen Per 100 patient years
Danish: Fuzeon + OB pr. 100 patientår
English: • This is given as a 1 ml injection just below the skin.
Danish: • Dette gives som en 1 ml indsprøjtning lige under huden.
English: gGrade 3= > 3 cm but ≤ 5 cm; Grade 4= > 5 cm.
Danish: gGrad 3 = >3 cm, men ≤5 cm; Grad 4 = >5 cm.
English: Clinical Pharmacodynamic data
Danish: Klinisk farmakodynamiske data
English: SPECIAL STORAGE CONDITIONS Keep the vial in the outer carton in order to protect from light After reconstitution store in a refrigerator
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevar hætteglasset i den ydre karton for at beskytte mod lys Opbevares efter rekonstituering i køleskab
English: The geometric mean changes ranged from 15.2 fold for V38M to 41.6 fold for V38A.
Danish: Den geometriske ændring i middelværdi varierede fra 15,2 gange for V38M til 41,6 gange for V38A.
English: If there is evidence of particulate matter, the vial must not be used and should be discarded or returned to the pharmacy.
Danish: Hvis der er tegn på partikler, må hætteglasset ikke anvendes og skal bortkastes eller returneres til apoteket.
English: Allow it to dry in the air completely.
Danish: Lad området lufttørre helt.
English: Marketing Authorisation Holder Roche Registration GmbH Emil-Barell-Strasse 1
Danish: Indehaver af markedsføringstilladelsen Roche Registration GmbH Emil-Barell-Strasse 1
English: You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy.
Danish: Du kan stadig smitte andre med hiv, når du er i behandling med denne medicin, selvom risikoen er mindre med effektiv antiretroviral behandling.
English: These substitutions were correlated with varying levels of reduced enfuvirtide susceptibility in HIV sitedirected mutants.
Danish: Substitutionerne blev korreleret med forskellige niveauer af nedsat enfuvirtid følsomhed hos specifikke hiv site-directed mutanter.
English: In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection.
Danish: Ud over de opportunistiske infektioner kan autoimmune lidelser (skyldes, at immunsystemet angriber sundt kropsvæv) også opstå, efter du er begyndt at tage medicin til behandling af din hiv-infektion.
English: Antiretroviral drug resistance: Incomplete viral suppression may lead to the development of drug resistance to one or more components of the regimen.
Danish: Antiretroviral lægemiddelresistens: Ufuldstændig viral suppression kan medføre udvikling af lægemiddelresistens over for en eller flere behandlingskomponenter.
English: Any inflammatory symptoms should be evaluated and treatment instituted when necessary.
Danish: Alle inflammatoriske symptomer bør vurderes, og behandling påbegyndes efter behov.
English: ● Once you have washed your hands, do not touch anything except the medicine and supplies.
Danish: • Når du har vasket hænder, må du ikke røre ved andet end medicinen og det medfølgende udstyr.
English: 180 alcohol swabs.
Danish: 180 spritservietter
English: Less than 13% of the dose was removed during haemodialysis.
Danish: Mindre end 13 % af dosis blev fjernet med hæmodialyse.
English: The Manufacturer responsible for batch release is Roche Pharma AG
Danish: Fremstiller ansvarlig for batchfrigivelse Roche Pharma AG
English: If it is not used straight away it must be stored in a refrigerator (2°C - 8°C) and used within 24 hours.
Danish: Hvis den ikke bruges med det samme, skal den opbevares i køleskab (2 °C - 8 °C) og bruges inden for 24 timer.
English: Administration of Fuzeon to non-HIV-1 infected individuals may induce anti-enfuvirtide antibodies that cross-react with HIV gp41.
Danish: Administration af Fuzeon til non-hiv-1-smittede personer kan inducere anti-enfuvirtid antistoffer, som krydsreagerer med hiv-gp41.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and late embryonal development.
Danish: De prækliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet og sen embryonal udvikling.
English: Other PK studies suggest no difference between Asians and Caucasians after adjusting exposure for body weight.
Danish: Andre farmakokinetiske studier tyder på, at der heller ikke er forskel mellem asiatere og kaukasere, når der er justeret for legemsvægt.
English: • you have ever had any lung problems
Danish: • du tidligere har haft nyreproblemer
English: After pulling out the needle
Danish: Når du har trukket nålen ud
English: Fuzeon is used for the treatment of Human Immune deficiency Virus (HIV) - in combination with other antiretroviral medicines in patients infected with HIV.
Danish: Fuzeon bruges til behandling af humant immundefekt-virus (hiv) i kombination med andre antiretrovirale lægemidler, hos patienter smittet med hiv.
English: This is where the bone tissue dies because the blood supply has been lost (death of bone tissue caused by loss of blood supply to the bone).
Danish: Her dør knoglevævet på grund af nedsat blodtilførsel til knoglen (dødt knoglevævforårsaget af nedsat blodtilførsel til knoglen).
English: Pinch as much of a skin fold as possible - without making yourself uncomfortable.
Danish: Tag så stor en hudfold som muligt og klem fast - ikke så det føles ubehageligt.
English: Slowly pull back the plunger until the water reaches the 1.1 ml mark.
Danish: Træk langsomt stemplet tilbage, indtil vandet når 1,1 ml mærket.
English: ● hardened skin or bumps
Danish: • hård hud eller buler
English: 60 vials of Fuzeon
Danish: 60 hætteglas Fuzeon
English: Patients should be instructed to discard the remaining volume in the solvent vials.
Danish: Patienten bør vejledes i, hvordan den resterende volumen i hætteglasset med solvens kasseres.
English: Once a dose is mixed with Water for Injections, it must be used straight away.
Danish: Når en dosis er blandet med vand til injektionsvæsker, skal den bruges med det samme.
English: Injection volume (90 mg enfuvirtide per ml)
Danish: Injektionsvolumen (90 mg enfuvirtid pr. ml)
English: Fuzeon contains the active substance enfuvirtide and belongs to a group of medicines called ‘antiretrovirals'.
Danish: Fuzeon indeholder det aktive stof enfuvirtid og tilhører gruppen af lægemidler, der kaldes antiretrovirale lægemidler.