natgillin/translations-raw huggingface dataset:
• Spørg lægen, apotekspersonalet på hospitalet eller sundhedspersonalet, hvis der er mere, du vil 
• If you have any further questions, ask your doctor, hospital pharmacist or nurse.
I kombination med cisplatin og 5-fluorouracil Docetaxel-dosis bør reduceres fra 75 til 60 mg/m2, hvis der trods anvendelse af G-CSF opstår: 1) febril neutropeni, 2) prolongeret neutropeni eller 3) neutropenisk infektion. 
If an episode of febrile neutropenia, prolonged neutropenia or neutropenic infection occurs despite G-CSF use, the docetaxel dose should be reduced from 75 to 60 mg/m2.
23,7 %); opkastning (G3/4: 14,3 
1.2%); Oedema (G3/4:
Øre og labyrint Hjerte 
Ear and labyrinth disorders Cardiac disorders
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. 
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.
Efter kemoterapi bør 
Following chemotherapy, patients should receive chemoradiotherapy.
3, 2) hos patienter, der får febril neutropeni, 3) hos patienter, med alvorlig, ikke-hæmatologisk toksicitet. 
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.
(G3/4: 12,0 %); konstipation (G3/4: 0,4 %) 
(G3/4: 1.2%); Dysgeusia (G3/4:
(Mulig mekanisme) 
(Possible mechanism)
(Studie udført med 8 patienter) 
(Study conducted in 8 patients)
Reaktionen kan være forsinket. 
This reaction may be delayed.
Ukendt mekanisme. 
Mechanism unknown.
GSS blev udledt ved anvendelse af ANRS 2007 guidelines. 
GSS was derived using ANRS 2007 guidelines.
Hos nogle patienter var administration af faktor VIII nødvendig. 
In some patients administration of factor VIII was necessary.
Derfor er det meget vigtigt, at du fortæller lægen om enhver ændring i dit helbred. 
For this reason, it is very important to talk to your doctor about any changes in your health.
Årsagen hertil er ukendt. 
The reason for this is not known.
• hvis man har været i kombinationsbehandling i lang tid 
• if they have been taking combination therapy for a long time
Det kan være nødvendigt med ekstra faktor VIII for at kontrollere en blødning 
You may need additional factor VIII to control any bleeding.
(Amprenavir uden ritonavir) 
(Amprenavir without ritonavir)
Disse indholdsstoffer kan forårsage allergiske reaktioner (nogle gange forsinket). 
These ingredients may cause allergic reactions (sometimes delayed).
Gentag punkt 4 til 8 indtil du har taget fuld dosis. 
Repeat steps 4 to 8 in the same way until you have taken the whole dose.
Vigtigheden af at overholde hele det anbefalede doseringsregime bør understreges over for alle patienter. 
The importance of complying with the full recommended dosing regimen should be stressed to all patients.
Der kan derfor ikke gives nogen anbefalinger for denne patientgruppe. 
Therefore, no recommendations can be made in this patient population.
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. 
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.
APVeksponering var 25-35 % lavere under graviditeten. 
APV exposure was 25-35% lower during pregnancy.
• problemer med at bevæge sig. 
• difficulty moving.
Idet der ikke foreligger kompatibilitetsstudier, må dette lægemiddel ikke blandes med andre lægemidler. 
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Pædiatrisk / andre populationer 
Paediatric / other populations
Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger. 
Like all medicines, this medicine can cause side effects, but not everyone gets them.
Resultaterne fra de 48 ugers behandling er angivet nedenfor. 
Results through 48 weeks of treatment are provided below.
Uge 48 AAUCMB (n) 
Week 48 AAUCMB (n)
Studie udført med amprenavir. 
Study performed with amprenavir.
 Fortæl lægen, hvis noget af dette gælder for dig. 
→Tell your doctor if any of these applies to you.
Disse stoffer kan forårsage en allergisk reaktion hos nogle personer. 
These products may cause an allergic reaction in some individuals.
Dette er baseret på sikkerhedsdata fra i alt 864 patienter eksponeret for fosamprenavir/ritonavir i disse tre studier. 
This is based on safety data from a total of 864 patients exposed to fosamprenavir/ritonavir in these three studies.
Da det ikke er muligt at opnå denne dosis af fosamprenavir med tabletformuleringen, bør disse patienter behandles med fosamprenavir oral suspension. 
As it is not possible to achieve this fosamprenavir dose using the tablet formulation, these patients should be treated with fosamprenavir oral suspension.
Voksne år) 
Adult years)
Desuden skal en opdateret RMP fremsendes 
An updated RMP should be submitted
Ved denne tilstand dør dele af knoglevævet på grund af nedsat blodforsyning til knoglerne. 
With this condition, parts of the bone tissue die because of reduced blood supply to the bone.
• hvis du tager nogen anden form for medicin. 
• If you are taking any other medicines.
Du skal gennemse listen af medicin under ”Tag ikke Telzir” i begyndelsen af punkt 2 i denne indlægsseddel. 
You must check the list of medicines under 'Don't take Telzir' at the beginning of section 2 of this leaflet.
Hvis din leversygdom forværres, skal du måske holde op med at tage Telzir for en tid eller permanent. 
If your liver disease gets worse, you may need to stop taking Telzir for a while, or permanently.
Anvendelsen af større doser ritonavir kan eventuelt føre til en ændret sikkerhedsprofil for kombinationen og kan derfor ikke anbefales. 
The use of higher ritonavir doses might alter the safety profile of the combination and therefore is not recommended.
Der er ikke foretaget sammenlignende studier med børn og unge. 
No comparative studies have been undertaken in children or adolescents.
Større påvirkning kan forventes, når fluticasonpropionat inhaleres. 
Greater effects may be expected when fluticasone propionate is inhaled.
Signifikant  APV forventet 
Significant ↓ APV expected
Tag ikke Telzir: 
Do not take Telzir:
Efter administration af Telzir er halveringstiden for amprenavir 7,7 timer. 
Following administration of Telzir, the half-life of amprenavir is 7.7 hours.
Hvis det sker for dig:  Tal med lægen med det samme. 
If this happens to you: →Talk to your doctor immediately.
• ømhed og smerter (især i hofte, knæ eller skulder) 
• aches and pains (especially in the hip, knee or shoulder)
Dosisjustering af midazolam bør overvejes, specielt hvis der skal gives mere end en enkelt dosis midazolam. 
Dosage adjustment for midazolam should be considered, especially if more than a single dose of midazolam is administered.
Hiv kan blive resistent over for anti-hiv-medicin. 
HIV can become resistant to anti-HIV medicines.
Telzir kan gøre dig svimmel og give andre bivirkninger, der gør dig mindre opmærksom. 
Telzir can make you feel dizzy and have other side effects that make you less alert.
Data fra et så lille antal patienter, hvor supplerende analyser er udført på GSS-undergrupper, skal fortolkes med forsigtighed. 
Data from this small number further analysed by GSS subgroups need to be interpreted with caution.
Avenida de Extremadura 3 09400 Aranda de Duero Burgos Spanien 
Avenida de Extremadura 3 09400 Aranda de Duero Burgos Spain
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. 
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.
GSS to OBT: Genotypic Sensitivity Score to Optimised Background. 
Key: 1GSS to OBT: Genotypic Sensitivity Score to Optimised Background.
< 6 år 
<6 years
I over halvdelen af de rapporterede tilfælde blev behandlingen med proteasehæmmere fortsat eller genoptaget, hvis den havde været afbrudt. 
In more than half of the reported cases, treatment with protease inhibitors was continued, or reintroduced if treatment had been discontinued.
Hvis det sker, skal du holde op med at tage Telzir med det samme, og du må aldrig tage det igen. 
If this happens, Telzir must be stopped immediately and you must never take it again.
Læs derfor oplysningerne i ”Andre bivirkninger ved kombinationsbehandling mod hiv” under punkt 4 i denne indlægsseddel. 
Please read the information on ‘Other side effects of combination therapy for HIV' in section 4 of this leaflet.
Du kan stadig få andre infektioner og sygdomme i forbindelse med din hiv-infektion. 
You may still develop other infections and illnesses linked to HIV infection.
Forsigtighed tilrådes, og tæt monitorering anbefales, når denne kombination gives til integrasehæmmer-resistente patienter. 
Caution is warranted and close monitoring is recommended when this combination is given in integrase inhibitorresistant patients.
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. 
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.
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. 
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.
Telzir bør kun anvendes under graviditet, hvis de potentielle fordele opvejer den potentielle risiko for fosteret. 
Telzir should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Nogle personer, som tager medicin mod hiv-infektion, kan udvikle andre tilstande, som kan være alvorlige. 
Some people taking medicines for HIV infection develop other conditions, which can be serious.
Amiodaron Bepridil Quinidin Flecainid Propafenon 
Amiodarone Bepridil Quinidine Flecainide Propafenone
Tidligere infektioner kan blusse op 
Old infections may flare up
Du skal tage Telzir hver dag for at undgå, at din sygdom forværres. 
You need to keep taking it every day to stop your illness getting worse.
Ved in vitro-studier er proteinbindingen af amprenavir ca. 90 %. 
In in vitro studies, the protein binding of amprenavir is approximately 90 %.
Disse symptomer skyldes normalt, at kroppens immunforsvar bliver stærkere, og kroppen begynder derfor at bekæmpe disse infektioner. 
These symptoms are probably caused by the body's immune system becoming stronger, so that the body starts to fight these infections.
• Aktivt stof: fosamprenavir. 
• The active substance is fosamprenavir.
AUC værdierne for fosamprenavir er generelt mindre end 1 % af værdierne observeret for amprenavir. 
Fosamprenavir AUC values are, in general, less than 1 % of those observed for amprenavir.
Dette er meget vigtigt, idet Telzir eller ritonavir kan forstærke eller nedsætte virkningen af anden medicin. 
This is very important, as Telzir or ritonavir can strengthen or weaken the effects of other medicines.
De fleste patienter med let eller moderat udslæt kan fortsætte med Telzir. 
Most patients with mild or moderate rash can continue Telzir.
• fluticasonpropionat og lignende medicin mod astma, medmindre dette skønnes nødvendigt. 
• fluticasone propionate and similar medicines used to treat asthma, unless considered essential.
Der findes ingen kendt antidot til Telzir. 
There is no known antidote for Telzir.
Der foreligger ingen humane data om effekten af fosamprenavir på fertilitet. 
No human data on the effect of fosamprenavir on fertility are available.
Suspension er hvid til off-white. 
The suspension is white to off-white.
(Læs indlægssedlen for Telzir oral suspension, der angiver, om det må tages med eller uden mad). 
(Read the package leaflet of Telzir oral suspension for guidance on whether to take it with or without food.)
Hvis der er tegn på forværring af leversygdommen hos patienterne, bør afbrydelse eller ophør af behandlingen overvejes. 
If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered.
• problemer med knoglerne. 
• Problems with your bones.
Patienter i alderen 12 til 18 år N=40 
Patients aged 12 to 18 N=40
Rekommandationer vedrørende samtidig administration 
Recommendation concerning coadministration
Du skal til ekstra kontrolbesøg og have taget ekstra blodprøver, mens du tager medicinen. 
You will need extra check-ups, including blood tests, while you're taking your medication.
Imidlertid fik kun 65 % af patienterne PI-baseret behandling ved studiets start. 
However, only 65 % of patients were receiving a PI based regimen at study entry.
Overordnet var bivirkningsprofilen hos disse 158 børn og unge identisk med bivirkningsprofilen observeret hos voksne. 
Overall the safety profile in these 158 children and adolescents was similar to that observed in the adult population.
Der er begrænset klinisk erfaring (mindre end 300 graviditetsudfald) om anvendelse af fosamprenavir til gravide kvinder. 
There is limited clinical experience (less than 300 pregnancy outcomes) from the use of fosamprenavir in pregnant women.
79 % af patienterne fik behandlingen i mere end 48 uger. 
79 % of subjects received greater than 48 weeks of exposure.
Hvis du har en moderat eller svær leversygdom skal dosis af Telzir reduceres. 
If you have moderate or severe liver disease the dose of Telzir has to be lowered.
Når disse personer begynder på behandlingen, kan de opleve, at skjulte infektioner blusser op og giver tegn og symptomer på betændelse. 
When these people start treatment, they may find that old, hidden infections flare up, causing signs and symptoms of inflammation.
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. 
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.
Træk i sprøjtens stempel indtil første del af din dosis er trukket ud. 
Pull out the syringe plunger until the first portion of your full dose is withdrawn.
Børn under 6 år Telzir bør ikke anvendes til børn under 6 år. 
Children less than 6 years of age Telzir is not recommended for children less than 6 years old.
Patienter i alderen 6 til 11 år N=30 
Patients aged 6 to 11 N=30
Fosamprenavir er et prodrug af amprenavir og må ikke administreres samtidig med andre lægemidler indeholdende amprenavir. 
Fosamprenavir is a pro-drug of amprenavir and must not be administered concomitantly with other medicinal products containing amprenavir.
Øget monitorering af den Internationale Normaliserede Ratio anbefales (se pkt. 
Reinforced monitoring of the International Normalised Ratio is recommended (see section 4.4).
Sværere og livstruende hudreaktioner, herunder Stevens-Johnsons syndrom, blev rapporteret hos færre end 1 % af patienterne i det kliniske udviklingsprogram. 
Severe and life-threatening skin reactions, including Stevens-Johnson syndrome, were reported in less than 1% of patients included in the clinical development programme.
Når Telzir administreres sammen med ritonavir er halveringstiden for amprenavir øget til 15-23 timer. 
When Telzir is co-administered with ritonavir, the half-life of amprenavir is increased to 15 - 23 hours.
Amprenavir er en kompetitiv hæmmer af hiv-1-proteasen. 
Amprenavir is a competitive inhibitor of the HIV-1 protease.
Nogle personer, som er i kombinationsbehandling mod hiv, udvikler en tilstand, der hedder osteonekrose. 
Some people taking combination therapy for HIV develop a condition called osteonecrosis.
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). 
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.
Der er fundet stoffer relateret til amprenavir i rottemælk, men det vides ikke, om amprenavir udskilles i human mælk. 
Amprenavir-related material was found in rat milk, but it is not known whether amprenavir is excreted in human milk.
Kvinder, som er hiv-positive, må ikke amme deres børn, fordi hiv-infektionen kan overføres til barnet med mælken. 
Women who are HIV-positive must not breast-feed because HIV infection can be passed on to the baby in breast milk.
Doseringsanbefalingerne til denne gruppe tager derfor højde for den observerede fødepåvirkning (se pkt. 
The dose recommendations for this population therefore take into account the observed food effect (see section 4.2).
Hvis du glemmer at tage en dosis Telzir, skal du tage den, så snart du husker det. Fortsæt derefter som før. 
If you forget to take a dose of Telzir, take it as soon as you remember and then continue your treatment as before.
Udslættet kan behandles med antihistaminer. 
It can be treated with antihistamines.
Der kan ikke gives doseringsanbefalinger til børn og unge med nedsat leverfunktion, da der ikke er udført studier med disse aldersgrupper. 
No dose recommendation can be made for children and adolescents with hepatic impairment as no studies have been conducted in these age groups.
Der er også personer, der får sukkersyge, mens de tager denne medicin 
Also, some people have become diabetic while taking these medicines.
Bioækvivalensen kunne ikke påvises når den orale suspension blev administreret med mad. 
However, the bioequivalence could not be demonstrated when the oral suspension was given with food.
Genotype-resistens-test 
Genotypic resistance testing
Kun relevant for ydre karton 
Only applicable to outer carton
Reduktionen i amprenavir AUC kan medføre virologisk svigt og resistensudvikling. 
The decrease in amprenavir AUC can result in virological failure and resistance development.
Relevante eksempler er cytomegalovirus retinitis, generaliserede og/eller fokale mykobakterielle infektioner og pneumocystis carinii pneumoni. 
Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterium infections, and Pneumocystis carinii pneumonia.
Andre bivirkninger ved kombinationsbehandling mod hiv 
Other side effects of combination therapy for HIV
Du skal kende vigtige tegn og symptomer, som du skal holde øje med, mens du tager Telzir. 
You need to know about important signs and symptoms to look out for while you're taking Telzir.
Der kan ikke gives doseringsanbefalinger til børn under 25 kg. 
No dosing recommendations can be made for children weighing less than 25 kg.
Resistensmønstre tilsvarede dem set hos voksne. 
Resistance patterns were similar to those observed in adults.
Denne justerede dosis er ikke blevet evalueret i et kliniske studie, men er afledt ud fra ekstrapolation (se pkt. 
This adjusted dose has not been evaluated in a clinical study and has been derived from extrapolation (see section 5.2).
Risiko for alvorlige og/eller livstruende reaktioner såsom hjertearytmier. 
Potential for serious and/or life-threatening reactions such as cardiac arrhythmias.
Øget blødning kan forekomme, mens du tager proteasehæmmere (som Telzir). 
Increased bleeding may occur while taking protease inhibitors (such as Telzir).
Industriestrasse 32-36 D-23843 Bad Oldesloe Tyskland eller 
Industriestrasse 32-36 D-23843 Bad Oldesloe Germany or
Synk tabletterne hele med vand eller anden væske. 
Swallow the tablets whole, with some water or another drink.
Genotypisk sensitivitetsscore i OBT 
Genotypic Sensitivity Score in OBT
I sjældne tilfælde har disse muskelsygdomme været alvorlige (rabdomyolyse). 
On rare occasions, these muscle disorders have been serious (rhabdomyolysis).
INHALEREDE/NASALE STEROIDER 
INHALED/NASAL STEROIDS
Sammenlignet med voksne dyr blev toksiciteten ikke forværret, når unge dyr blev behandlet, men data indikerede et stejlere dosisresponsforløb. 
Toxicity was not aggravated when juvenile animals were treated as compared with adult animals, but the data did indicate a steeper dose response.
Hos rotter eksponeret før og efter fødsel med fosamprenavir viste ungerne nedsat fysisk og funktionel udvikling samt reduceret vækst. 
In rats exposed pre- and post-natally to fosamprenavir, pups showed impaired physical and functional development and reduced growth.
Lidocain (systemisk) 
Lidocaine (by systemic route)
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. 
Protease is an enzyme produced by HIV which enables the virus to multiply in white blood cells (CD4 cells) in your blood.
CCR5-receptor-antagonister 
CCR5-receptor antagonists
Risikoen for krydsoverfølsomhed mellem lægemidler i sulfonamidgruppen og fosamprenavir er ukendt. 
The potential for cross-sensitivity between medicinal products in the sulphonamide class and fosamprenavir is unknown.
Hvis du ønsker yderligere oplysninger om dette lægemiddel, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen: 
For any information about this medicinal product please contact the local representative of the Marketing Authorisation Holder.
ITT(Ext) population TLOVR analyse 
ITT (Ext) Population TLOVR analysis
Patienter med nedsat nyrefunktion er ikke undersøgt specifikt. 
Patients with renal impairment have not been specifically studied.
Hæmofilipatienter bør derfor gøres opmærksom på muligheden for øget blødningstendens. 
Haemophiliac patients should therefore be informed of the possibility of increased bleeding.
Personer med fremskreden hiv-infektion (aids) har et svækket immunforsvar og har større risiko for at udvikle alvorlige infektioner (opportunistiske infektioner). 
People with advanced HIV infection (AIDS) have weak immune systems and are more likely to develop serious infections (opportunistic infections).
Alligevel bør Telzir foreløbig anvendes med forsigtighed til patienter med kendt sulfonamidallergi. 
Yet, Telzir should be used with caution in patients with a known sulphonamide allergy.
• opblussen af tidligere infektioner 
• Flare up of old infections
Som vist i tabellen ovenfor var der kun 16 patienter med baseline-virus med resistens over for FPV/RTV ifølge ANRS-score. 
As shown in the above table, there were only 16 patients harbouring baseline virus with resistance to FPV/RTV according to the ANRS score.