FrancophonIA/ELRC3.0 huggingface dataset:
English: In study GEICAM 9805 peripheral oedema that started during the treatment period persisted into the follow-up period in 4 patients (0.8%) in TAC arm and in 2 patients (0.4%) in FAC arm. At the end of the follow-up period (median follow-up time of 10 years and 5 months), no patients (0%) in TAC arm had peripheral oedema and it was observed to be ongoing in 1 patient (0.2%) in FAC arm. Lymphoedema that started during the treatment period persisted into the follow-up period in 5 patients (0.9%) in TAC arm and 2 patients (0.4 %) in FAC arm. At the end of the follow-up period, lymphoedema was observed to be ongoing in 4 patients (0.8%) in TAC arm, and in 1 patient (0.2%) in FAC arm.
Danish: I studiet GEICAM 9805 blev det observeret, at perifert ødem, som forekom i løbet af behandlingsperioden, fortsatte ind i opfølgningsperioden hos 4 patienter (0,8 %) i TAC-armen og hos 2 patienter (0,4 %) i FAC-armen.
English: Following chemotherapy, patients should receive chemoradiotherapy.
Danish: Efter kemoterapi bør
English: 3, or in patients who experience febrile neutropenia, or in patients with serious non-haematologic toxicities, the docetaxel dose in subsequent cycles should be reduced to 65 mg/m2.
Danish: 3, 2) hos patienter, der får febril neutropeni, 3) hos patienter, med alvorlig, ikke-hæmatologisk toksicitet.
English: (G3/4: 1.2%); Dysgeusia (G3/4:
Danish: (G3/4: 12,0 %); konstipation (G3/4: 0,4 %)
English: (Possible mechanism)
Danish: (Mulig mekanisme)
English: (Study conducted in 8 patients)
Danish: (Studie udført med 8 patienter)
English: This reaction may be delayed.
Danish: Reaktionen kan være forsinket.
English: Mechanism unknown.
Danish: Ukendt mekanisme.
English: GSS was derived using ANRS 2007 guidelines.
Danish: GSS blev udledt ved anvendelse af ANRS 2007 guidelines.
English: In some patients administration of factor VIII was necessary.
Danish: Hos nogle patienter var administration af faktor VIII nødvendig.
English: For this reason, it is very important to talk to your doctor about any changes in your health.
Danish: Derfor er det meget vigtigt, at du fortæller lægen om enhver ændring i dit helbred.
English: The reason for this is not known.
Danish: Årsagen hertil er ukendt.
English: • if they have been taking combination therapy for a long time
Danish: • hvis man har været i kombinationsbehandling i lang tid
English: You may need additional factor VIII to control any bleeding.
Danish: Det kan være nødvendigt med ekstra faktor VIII for at kontrollere en blødning
English: (Amprenavir without ritonavir)
Danish: (Amprenavir uden ritonavir)
English: These ingredients may cause allergic reactions (sometimes delayed).
Danish: Disse indholdsstoffer kan forårsage allergiske reaktioner (nogle gange forsinket).
English: Repeat steps 4 to 8 in the same way until you have taken the whole dose.
Danish: Gentag punkt 4 til 8 indtil du har taget fuld dosis.
English: The importance of complying with the full recommended dosing regimen should be stressed to all patients.
Danish: Vigtigheden af at overholde hele det anbefalede doseringsregime bør understreges over for alle patienter.
English: Therefore, no recommendations can be made in this patient population.
Danish: Der kan derfor ikke gives nogen anbefalinger for denne patientgruppe.
English: To avoid this happening, and to stop your illness getting worse, it is very important that you keep taking all your medicines exactly as prescribed.
Danish: For at undgå, at dette sker, og for at forhindre, at din sygdom forværres, er det meget vigtigt, at du tager al din medicin efter lægens anvisning.
English: APV exposure was 25-35% lower during pregnancy.
Danish: APVeksponering var 25-35 % lavere under graviditeten.
English: • difficulty moving.
Danish: • problemer med at bevæge sig.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Danish: Idet der ikke foreligger kompatibilitetsstudier, må dette lægemiddel ikke blandes med andre lægemidler.
English: Paediatric / other populations
Danish: Pædiatrisk / andre populationer
English: Like all medicines, this medicine can cause side effects, but not everyone gets them.
Danish: Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Results through 48 weeks of treatment are provided below.
Danish: Resultaterne fra de 48 ugers behandling er angivet nedenfor.
English: Week 48 AAUCMB (n)
Danish: Uge 48 AAUCMB (n)
English: Study performed with amprenavir.
Danish: Studie udført med amprenavir.
English: →Tell your doctor if any of these applies to you.
Danish:  Fortæl lægen, hvis noget af dette gælder for dig.
English: These products may cause an allergic reaction in some individuals.
Danish: Disse stoffer kan forårsage en allergisk reaktion hos nogle personer.
English: This is based on safety data from a total of 864 patients exposed to fosamprenavir/ritonavir in these three studies.
Danish: Dette er baseret på sikkerhedsdata fra i alt 864 patienter eksponeret for fosamprenavir/ritonavir i disse tre studier.
English: As it is not possible to achieve this fosamprenavir dose using the tablet formulation, these patients should be treated with fosamprenavir oral suspension.
Danish: Da det ikke er muligt at opnå denne dosis af fosamprenavir med tabletformuleringen, bør disse patienter behandles med fosamprenavir oral suspension.
English: Adult years)
Danish: Voksne år)
English: An updated RMP should be submitted
Danish: Desuden skal en opdateret RMP fremsendes
English: With this condition, parts of the bone tissue die because of reduced blood supply to the bone.
Danish: Ved denne tilstand dør dele af knoglevævet på grund af nedsat blodforsyning til knoglerne.
English: • If you are taking any other medicines.
Danish: • hvis du tager nogen anden form for medicin.
English: You must check the list of medicines under 'Don't take Telzir' at the beginning of section 2 of this leaflet.
Danish: Du skal gennemse listen af medicin under ”Tag ikke Telzir” i begyndelsen af punkt 2 i denne indlægsseddel.
English: If your liver disease gets worse, you may need to stop taking Telzir for a while, or permanently.
Danish: Hvis din leversygdom forværres, skal du måske holde op med at tage Telzir for en tid eller permanent.
English: The use of higher ritonavir doses might alter the safety profile of the combination and therefore is not recommended.
Danish: Anvendelsen af større doser ritonavir kan eventuelt føre til en ændret sikkerhedsprofil for kombinationen og kan derfor ikke anbefales.
English: No comparative studies have been undertaken in children or adolescents.
Danish: Der er ikke foretaget sammenlignende studier med børn og unge.
English: Greater effects may be expected when fluticasone propionate is inhaled.
Danish: Større påvirkning kan forventes, når fluticasonpropionat inhaleres.
English: Significant ↓ APV expected
Danish: Signifikant  APV forventet
English: Do not take Telzir:
Danish: Tag ikke Telzir:
English: Following administration of Telzir, the half-life of amprenavir is 7.7 hours.
Danish: Efter administration af Telzir er halveringstiden for amprenavir 7,7 timer.
English: If this happens to you: →Talk to your doctor immediately.
Danish: Hvis det sker for dig:  Tal med lægen med det samme.
English: • aches and pains (especially in the hip, knee or shoulder)
Danish: • ømhed og smerter (især i hofte, knæ eller skulder)
English: Dosage adjustment for midazolam should be considered, especially if more than a single dose of midazolam is administered.
Danish: Dosisjustering af midazolam bør overvejes, specielt hvis der skal gives mere end en enkelt dosis midazolam.
English: HIV can become resistant to anti-HIV medicines.
Danish: Hiv kan blive resistent over for anti-hiv-medicin.
English: Telzir can make you feel dizzy and have other side effects that make you less alert.
Danish: Telzir kan gøre dig svimmel og give andre bivirkninger, der gør dig mindre opmærksom.
English: Data from this small number further analysed by GSS subgroups need to be interpreted with caution.
Danish: Data fra et så lille antal patienter, hvor supplerende analyser er udført på GSS-undergrupper, skal fortolkes med forsigtighed.
English: Avenida de Extremadura 3 09400 Aranda de Duero Burgos Spain
Danish: Avenida de Extremadura 3 09400 Aranda de Duero Burgos Spanien
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: Indehaveren af markedsføringstilladelsen skal fremsende periodiske, opdaterede sikkerhedsindberetninger (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/EC og offentliggjort på den europæiske webportal for lægemidler.
English: Key: 1GSS to OBT: Genotypic Sensitivity Score to Optimised Background.
Danish: GSS to OBT: Genotypic Sensitivity Score to Optimised Background.
English: <6 years
Danish: < 6 år
English: In more than half of the reported cases, treatment with protease inhibitors was continued, or reintroduced if treatment had been discontinued.
Danish: I over halvdelen af de rapporterede tilfælde blev behandlingen med proteasehæmmere fortsat eller genoptaget, hvis den havde været afbrudt.
English: If this happens, Telzir must be stopped immediately and you must never take it again.
Danish: Hvis det sker, skal du holde op med at tage Telzir med det samme, og du må aldrig tage det igen.
English: Please read the information on ‘Other side effects of combination therapy for HIV' in section 4 of this leaflet.
Danish: Læs derfor oplysningerne i ”Andre bivirkninger ved kombinationsbehandling mod hiv” under punkt 4 i denne indlægsseddel.
English: You may still develop other infections and illnesses linked to HIV infection.
Danish: Du kan stadig få andre infektioner og sygdomme i forbindelse med din hiv-infektion.
English: Caution is warranted and close monitoring is recommended when this combination is given in integrase inhibitorresistant patients.
Danish: Forsigtighed tilrådes, og tæt monitorering anbefales, når denne kombination gives til integrasehæmmer-resistente patienter.
English: Following completion of the 48 week treatment period, subjects at European and Canadian sites were eligible to participate in a study extension to Week 144 maintaining their treatment regimen as per the original randomisation.
Danish: Efter fuldførelse af behandlingsperioden på 48 uger, opfyldte patienter på de europæiske og canadiske sites kriterierne for at deltage i et forlængelsesstudie indtil uge 144, hvor deres behandlingsregime blev fastholdt som under den oprindelige randomisering.
English: If you are pregnant, think you may be pregnant, or are planning to have a baby: →Ask your doctor or pharmacist for advice before taking this medicine.
Danish: Hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid:  Spørg din læge eller apotekspersonalet til råds, før du tager dette lægemiddel.
English: Telzir should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Danish: Telzir bør kun anvendes under graviditet, hvis de potentielle fordele opvejer den potentielle risiko for fosteret.
English: Some people taking medicines for HIV infection develop other conditions, which can be serious.
Danish: Nogle personer, som tager medicin mod hiv-infektion, kan udvikle andre tilstande, som kan være alvorlige.
English: Amiodarone Bepridil Quinidine Flecainide Propafenone
Danish: Amiodaron Bepridil Quinidin Flecainid Propafenon
English: Old infections may flare up
Danish: Tidligere infektioner kan blusse op
English: You need to keep taking it every day to stop your illness getting worse.
Danish: Du skal tage Telzir hver dag for at undgå, at din sygdom forværres.
English: In in vitro studies, the protein binding of amprenavir is approximately 90 %.
Danish: Ved in vitro-studier er proteinbindingen af amprenavir ca. 90 %.
English: These symptoms are probably caused by the body's immune system becoming stronger, so that the body starts to fight these infections.
Danish: Disse symptomer skyldes normalt, at kroppens immunforsvar bliver stærkere, og kroppen begynder derfor at bekæmpe disse infektioner.
English: • The active substance is fosamprenavir.
Danish: • Aktivt stof: fosamprenavir.
English: Fosamprenavir AUC values are, in general, less than 1 % of those observed for amprenavir.
Danish: AUC værdierne for fosamprenavir er generelt mindre end 1 % af værdierne observeret for amprenavir.
English: This is very important, as Telzir or ritonavir can strengthen or weaken the effects of other medicines.
Danish: Dette er meget vigtigt, idet Telzir eller ritonavir kan forstærke eller nedsætte virkningen af anden medicin.
English: Most patients with mild or moderate rash can continue Telzir.
Danish: De fleste patienter med let eller moderat udslæt kan fortsætte med Telzir.
English: • fluticasone propionate and similar medicines used to treat asthma, unless considered essential.
Danish: • fluticasonpropionat og lignende medicin mod astma, medmindre dette skønnes nødvendigt.
English: There is no known antidote for Telzir.
Danish: Der findes ingen kendt antidot til Telzir.
English: No human data on the effect of fosamprenavir on fertility are available.
Danish: Der foreligger ingen humane data om effekten af fosamprenavir på fertilitet.
English: The suspension is white to off-white.
Danish: Suspension er hvid til off-white.
English: (Read the package leaflet of Telzir oral suspension for guidance on whether to take it with or without food.)
Danish: (Læs indlægssedlen for Telzir oral suspension, der angiver, om det må tages med eller uden mad).
English: If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered.
Danish: Hvis der er tegn på forværring af leversygdommen hos patienterne, bør afbrydelse eller ophør af behandlingen overvejes.
English: • Problems with your bones.
Danish: • problemer med knoglerne.
English: Patients aged 12 to 18 N=40
Danish: Patienter i alderen 12 til 18 år N=40
English: Recommendation concerning coadministration
Danish: Rekommandationer vedrørende samtidig administration
English: You will need extra check-ups, including blood tests, while you're taking your medication.
Danish: Du skal til ekstra kontrolbesøg og have taget ekstra blodprøver, mens du tager medicinen.
English: However, only 65 % of patients were receiving a PI based regimen at study entry.
Danish: Imidlertid fik kun 65 % af patienterne PI-baseret behandling ved studiets start.
English: Overall the safety profile in these 158 children and adolescents was similar to that observed in the adult population.
Danish: Overordnet var bivirkningsprofilen hos disse 158 børn og unge identisk med bivirkningsprofilen observeret hos voksne.
English: There is limited clinical experience (less than 300 pregnancy outcomes) from the use of fosamprenavir in pregnant women.
Danish: Der er begrænset klinisk erfaring (mindre end 300 graviditetsudfald) om anvendelse af fosamprenavir til gravide kvinder.
English: 79 % of subjects received greater than 48 weeks of exposure.
Danish: 79 % af patienterne fik behandlingen i mere end 48 uger.
English: If you have moderate or severe liver disease the dose of Telzir has to be lowered.
Danish: Hvis du har en moderat eller svær leversygdom skal dosis af Telzir reduceres.
English: When these people start treatment, they may find that old, hidden infections flare up, causing signs and symptoms of inflammation.
Danish: Når disse personer begynder på behandlingen, kan de opleve, at skjulte infektioner blusser op og giver tegn og symptomer på betændelse.
English: It should be noted that the Telzir oral suspension has not been evaluated clinically in adults and that the adverse reaction profile detailed in this section is based on the experience in adults with the Telzir film coated tablets.
Danish: Det skal bemærkes, at Telzir oral suspension ikke er blevet evalueret klinisk hos voksne, og at bivirkningsprofilen i dette afsnit er baseret på erfaringer hos voksne med Telzir filmovertrukne tabletter.
English: Pull out the syringe plunger until the first portion of your full dose is withdrawn.
Danish: Træk i sprøjtens stempel indtil første del af din dosis er trukket ud.
English: Children less than 6 years of age Telzir is not recommended for children less than 6 years old.
Danish: Børn under 6 år Telzir bør ikke anvendes til børn under 6 år.
English: Patients aged 6 to 11 N=30
Danish: Patienter i alderen 6 til 11 år N=30
English: Fosamprenavir is a pro-drug of amprenavir and must not be administered concomitantly with other medicinal products containing amprenavir.
Danish: Fosamprenavir er et prodrug af amprenavir og må ikke administreres samtidig med andre lægemidler indeholdende amprenavir.
English: Reinforced monitoring of the International Normalised Ratio is recommended (see section 4.4).
Danish: Øget monitorering af den Internationale Normaliserede Ratio anbefales (se pkt.
English: Severe and life-threatening skin reactions, including Stevens-Johnson syndrome, were reported in less than 1% of patients included in the clinical development programme.
Danish: Sværere og livstruende hudreaktioner, herunder Stevens-Johnsons syndrom, blev rapporteret hos færre end 1 % af patienterne i det kliniske udviklingsprogram.
English: When Telzir is co-administered with ritonavir, the half-life of amprenavir is increased to 15 - 23 hours.
Danish: Når Telzir administreres sammen med ritonavir er halveringstiden for amprenavir øget til 15-23 timer.
English: Amprenavir is a competitive inhibitor of the HIV-1 protease.
Danish: Amprenavir er en kompetitiv hæmmer af hiv-1-proteasen.
English: Some people taking combination therapy for HIV develop a condition called osteonecrosis.
Danish: Nogle personer, som er i kombinationsbehandling mod hiv, udvikler en tilstand, der hedder osteonekrose.
English: Frequencies are defined as: 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) or Very rare (< 1/10,000), or Not known.
Danish: Frekvenserne er defineret som: 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), meget sjælden (< 1/10.000) eller ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Amprenavir-related material was found in rat milk, but it is not known whether amprenavir is excreted in human milk.
Danish: Der er fundet stoffer relateret til amprenavir i rottemælk, men det vides ikke, om amprenavir udskilles i human mælk.
English: Women who are HIV-positive must not breast-feed because HIV infection can be passed on to the baby in breast milk.
Danish: Kvinder, som er hiv-positive, må ikke amme deres børn, fordi hiv-infektionen kan overføres til barnet med mælken.
English: The dose recommendations for this population therefore take into account the observed food effect (see section 4.2).
Danish: Doseringsanbefalingerne til denne gruppe tager derfor højde for den observerede fødepåvirkning (se pkt.
English: If you forget to take a dose of Telzir, take it as soon as you remember and then continue your treatment as before.
Danish: Hvis du glemmer at tage en dosis Telzir, skal du tage den, så snart du husker det. Fortsæt derefter som før.
English: It can be treated with antihistamines.
Danish: Udslættet kan behandles med antihistaminer.
English: No dose recommendation can be made for children and adolescents with hepatic impairment as no studies have been conducted in these age groups.
Danish: Der kan ikke gives doseringsanbefalinger til børn og unge med nedsat leverfunktion, da der ikke er udført studier med disse aldersgrupper.
English: Also, some people have become diabetic while taking these medicines.
Danish: Der er også personer, der får sukkersyge, mens de tager denne medicin
English: However, the bioequivalence could not be demonstrated when the oral suspension was given with food.
Danish: Bioækvivalensen kunne ikke påvises når den orale suspension blev administreret med mad.
English: Genotypic resistance testing
Danish: Genotype-resistens-test
English: Only applicable to outer carton
Danish: Kun relevant for ydre karton
English: The decrease in amprenavir AUC can result in virological failure and resistance development.
Danish: Reduktionen i amprenavir AUC kan medføre virologisk svigt og resistensudvikling.
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterium infections, and Pneumocystis carinii pneumonia.
Danish: Relevante eksempler er cytomegalovirus retinitis, generaliserede og/eller fokale mykobakterielle infektioner og pneumocystis carinii pneumoni.
English: Other side effects of combination therapy for HIV
Danish: Andre bivirkninger ved kombinationsbehandling mod hiv
English: You need to know about important signs and symptoms to look out for while you're taking Telzir.
Danish: Du skal kende vigtige tegn og symptomer, som du skal holde øje med, mens du tager Telzir.
English: No dosing recommendations can be made for children weighing less than 25 kg.
Danish: Der kan ikke gives doseringsanbefalinger til børn under 25 kg.
English: Resistance patterns were similar to those observed in adults.
Danish: Resistensmønstre tilsvarede dem set hos voksne.
English: This adjusted dose has not been evaluated in a clinical study and has been derived from extrapolation (see section 5.2).
Danish: Denne justerede dosis er ikke blevet evalueret i et kliniske studie, men er afledt ud fra ekstrapolation (se pkt.
English: Potential for serious and/or life-threatening reactions such as cardiac arrhythmias.
Danish: Risiko for alvorlige og/eller livstruende reaktioner såsom hjertearytmier.
English: Increased bleeding may occur while taking protease inhibitors (such as Telzir).
Danish: Øget blødning kan forekomme, mens du tager proteasehæmmere (som Telzir).
English: Industriestrasse 32-36 D-23843 Bad Oldesloe Germany or
Danish: Industriestrasse 32-36 D-23843 Bad Oldesloe Tyskland eller
English: Swallow the tablets whole, with some water or another drink.
Danish: Synk tabletterne hele med vand eller anden væske.
English: Genotypic Sensitivity Score in OBT
Danish: Genotypisk sensitivitetsscore i OBT
English: On rare occasions, these muscle disorders have been serious (rhabdomyolysis).
Danish: I sjældne tilfælde har disse muskelsygdomme været alvorlige (rabdomyolyse).
English: INHALED/NASAL STEROIDS
Danish: INHALEREDE/NASALE STEROIDER
English: Toxicity was not aggravated when juvenile animals were treated as compared with adult animals, but the data did indicate a steeper dose response.
Danish: Sammenlignet med voksne dyr blev toksiciteten ikke forværret, når unge dyr blev behandlet, men data indikerede et stejlere dosisresponsforløb.
English: In rats exposed pre- and post-natally to fosamprenavir, pups showed impaired physical and functional development and reduced growth.
Danish: Hos rotter eksponeret før og efter fødsel med fosamprenavir viste ungerne nedsat fysisk og funktionel udvikling samt reduceret vækst.
English: Lidocaine (by systemic route)
Danish: Lidocain (systemisk)
English: Protease is an enzyme produced by HIV which enables the virus to multiply in white blood cells (CD4 cells) in your blood.
Danish: Protease er et enzym, der produceres af hiv, og som gør virusset i stand til at formere sig i de hvide blodlegemer (CD4-celler) i blodet.
English: CCR5-receptor antagonists
Danish: CCR5-receptor-antagonister
English: The potential for cross-sensitivity between medicinal products in the sulphonamide class and fosamprenavir is unknown.
Danish: Risikoen for krydsoverfølsomhed mellem lægemidler i sulfonamidgruppen og fosamprenavir er ukendt.
English: For any information about this medicinal product please contact the local representative of the Marketing Authorisation Holder.
Danish: Hvis du ønsker yderligere oplysninger om dette lægemiddel, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen: