natgillin/translations-raw huggingface dataset:
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.
Samtidig administration af Telzir og quetiapin er kontraindiceret, da det kan medføre øget quetiapinrelateret toksicitet.
Concomitant administration of Telzir and quetiapine is contra-indicated as it may increase quetiapine-related toxicity.
Telzir indeholder
What Telzir contains
Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
Don't take a double dose to make up for a missed dose.
Sammenhængen mellem amprenavirs in vitro-anti-hiv-1-aktivitet og hæmningen af hiv-1-replikationen i mennesker kendes ikke.
The relationship between in vitro anti-HIV-1 activity of amprenavir and the inhibition of HIV-1 replication in humans has not been defined.
Alle patienter, RD = F analyse n (%)
All Patients, RD=F Analysis2
• clarithromycin, erythromycin (antibiotika)
• clarithromycin, erythromycin (an antibiotic)
Der kan ikke gives doseringsvejledning.
No dose recommendations can be given.
Det vides ikke, om nogle af indholdsstofferne i Telzir også kan udskilles i mælken.
It is not known whether the ingredients in Telzir can also pass into your breast milk.
Disse tilstande er:
These include:
Ryst flasken 5 sekunder før efterfølgende brug.
Shake the bottle for 5 seconds before subsequent uses.
Den indrullerede patientgruppe bestod for hovedparten af moderat antiretroviral-erfarne patienter.
The population enrolled mainly consisted of moderately antiretroviral experienced patients.
Tryk langsomt på stemplet, så der er tid til at synke.
Slowly push the plunger in, allowing time to swallow.
Midazolam:  forventet (3-4 fold ved parenteral midazolam)
Midazolam: ↑ expected (3-4 fold for parenteral midazolam)
Det tages sammen med lave doser af en anden medicin, ritonavir, som forøger mængden af Telzir i blodet.
It is taken with low doses of another medicine, ritonavir, which boosts the level of Telzir in the blood.
Det anbefales at måle phenytoins plasmakoncentration og om nødvendigt øge dosis af phenytoin.
It is recommended that phenytoin plasma concentrations be monitored and phenytoin dose increased as appropriate.
Hos nogle patienter, der tager antiretroviral medicin, herunder proteasehæmmere, er der set forhøjet sukker i blodet og forværring af sukkersyge.
In some patients taking antiretroviral medicines including protease inhibitors, there have been reports of increased sugar in the blood and diabetes getting worse.
Den absolutte biotilgængelighed af fosamprenavir i mennesker kendes ikke.
The absolute bioavailability of fosamprenavir in humans has not been established.
Ciclosporin Rapamycin Tacrolimus
Cyclosporin Rapamycin Tacrolimus
Frekvenskategorierne for nedennævnte bivirkninger er baseret på kliniske studier og data efter markedsføringen.
Frequency categories for the reactions below have been based on clinical trials and postmarketing data.
Risikoen for tumorer i thyreoidea anses for at være artsspecifik.
The thyroid tumorigenic potential is regarded to be species-specific.
Kun 22 % af den oprindelige population af KLEAN-studiet blev medtaget i forlængelsesstudiet.
Only 22% of the original population of the KLEAN study was enrolled in the study extension.
Hyppig monitorering af terapeutiske koncentrationer af immunsuppressiva anbefales, indtil niveauerne er stabiliseret (se pkt.
Frequent therapeutic concentration monitoring of immunosuppressant levels is recommended until levels have stabilised (see section
Disse data er yderligere dokumenteret i det underbyggende studie APV20003; dog blev der i dette studie anvendt en anden dosering end den anvendt i studie APV29005.
These data were further substantiated by the supportive study APV20003; however, a different dosage regimen than that of study APV29005 was used.
En nedsættelse af rifabutindosis på mindst 75 % anbefales, når rifabutin administreres samtidig med Telzir og ritonavir.
A reduction in the rifabutin dosage by at least 75 % is recommended when administered with Telzir with ritonavir.
Denne værdi nedsættes med ca. 40 %, når Telzir administreres sammen med ritonavir, muligvis pga. amprenavirs øgede biotilgængelighed.
This value is decreased by approximately 40 % when Telzir is co-administered with ritonavir, most likely due to an increase in amprenavir bioavailability.
Risiko for øgede koncentrationer af alfuzosin, hvilket kan medføre hypotension.
Potential for increased alfuzosin concentrations which can result in hypotension.
Sprøjte og adapter tages af flasken og vaskes grundigt i rent vand.
Take the syringe and the adapter off and wash them thoroughly in clean water.
Kapsler eller opløsning
Capsule or Solution
• methadon (erstatning for heroin)
• methadone (a heroin substitute)
RD = F: ”Rebound or discontinuation” er lig med “failure”-analyse, som er ækvivalent med TLOVR.
2RD=F: Rebound or discontinuation equal failure analysis which is equivalent to TLOVR.
Glaxo Operations UK Ltd (registreret som GlaxoWellcome Operations)
Glaxo Operations UK Ltd (trading as GlaxoWellcome Operations)
Opkastning forekom oftere blandt pædiatriske patienter.
Vomiting occurred more frequently amongst paediatric patients.
Efter en enkelt dosis af fosamprenavir ses den maksimale plasmakoncentrationen for amprenavir ca. 2 timer efter administrationen.
After single dose administration of fosamprenavir, amprenavir peak plasma concentrations are observed approximately 2 hours after administration.
Tag ikke anden medicin mod infektionen, medmindre lægen anbefaler det.
Don't take other medicines for the infection without your doctor's advice.
 Brug derfor anden ikke-hormonel prævention, f.eks. kondom.
→ Use an alternative non-hormonal type of contraception such as a condom.
Krampestillende lægemidler (carbamazepin, phenobarbital) bør anvendes med forsigtighed.
Anticonvulsants (carbamazepine, phenobarbital) should be used with caution.
Du vil blive fulgt tættere, mens du tager Telzir.
You will be monitored while you are taking Telzir.
• følelsesløshed eller prikkende fornemmelse omkring munden og læberne.
• Tingling or numbness around the lips and mouth.
Alternative ikke-hormonale kontraceptionsmetoder anbefales til kvinder i den fødedygtige alder (se pkt.
Alternative non-hormonal methods of contraception are recommended for women of childbearing potential (see section 4.4).
Ritonavir inducerer CYP3A4, CYP1A2, CYP2C9 og glucuronosyltransferase.
Ritonavir induces CYP3A4, CYP1A2, CYP2C9 and glucuronosyl transferase.
Farmakokinetikken af fosamprenavir i kombination med ritonavir er ikke blevet undersøgt hos patienter over 65 år.
The pharmacokinetics of fosamprenavir in combination with ritonavir has not been studied in patients over 65 years of age.
• lidocain som injektion
• lidocaine given by injection
Ydermere var antallet af implantationssteder per kuld nedsat og gestationsperioden var forlænget hos ungerne, når disse efter at være blevet kønsmodne blev parret.
In addition, decreased number of implantation sites per litter and a prolongation of gestation were seen when pups were mated after reaching maturity.
Telzir hjælper med at holde din sygdom under kontrol, men det helbreder ikke hiv-infektion.
Telzir helps to control your condition, but it is not a cure for HIV infection.
Stigningen af 25-Odesacetylrifabutin (aktiv metabolit) kan potentielt medføre en stigning af rifabutinrelaterede bivirkninger, især uveitis.
The increase of 25-Odesacetylrifabutin (active metabolite) could potentially lead to an increase of rifabutin related adverse events, notably uveitis.
Reduktion af Telzirdosis kan være nødvendig (anvend oral suspension).
Telzir may require dose reduction (using oral suspension).
Pædiatriske patienter fra 6 år
Paediatric patients from 6 years of age
Hvis du får symptomer på en infektion eller tegn på inflammation (en betændelseslignende reaktion), mens du tager Telzir:  Tal med lægen med det samme.
If you get any symptoms of infection or signs of inflammation while you're taking Telzir: →Tell your doctor immediately.
• forhøjet kolesterol (en type fedt i blodet).
• Increase in cholesterol (a type of blood fat).
I de pivotale studier af Telzir, med patienter behandlet med fosamprenavir og ritonavir, fandt man ingen tegn på forøget risiko for udslæt hos patienter med kendt sulfonamidallergi, sammenlignet med patienter som ikke havde sulfonamidallergi.
In the pivotal studies of Telzir, in patients receiving fosamprenavir with ritonavir there was no evidence of an increased risk of rashes in patients with a history of sulphonamide allergy versus those who did not have a sulphonamide allergy.
(Ritonavir 100 mg kapsler 2 gange daglig i 7 dage)
(Ritonavir 100 mg capsules twice daily for 7 days)
• forhøjede triglycerider (en type fedt i blodet).
• Increases in triglycerides (a type of blood fat).
AAUCMB observeret analyse
AAUCMB Observed Analysis
Mulig  eller  af antitrombotisk virkning.
Possible ↓ or ↑ of antithrombotic effect.
Høje doser (> 200 mg/dag) af ketoconazol eller itraconazol frarådes.
High doses (> 200 mg/day) of ketoconazole or itraconazole are not recommended.
Mindre end 1 % af den terapeutiske dosis af amprenavir udskilles uændret i urinen.
Less than 1 % of the therapeutic dose of amprenavir is excreted unchanged in the urine.
Det er vist, at koncentrationen af AAG falder under antiretrovirale behandlingsforløb.
Concentrations of AAG have been shown to decrease during the course of antiretroviral therapy.
• warfarin og anden medicin mod blodpropper
• warfarin and other medicines that stop blood clotting
Dato for første markedsføringstilladelse: 12. juli 2004 Dato for seneste fornyelse: 15. maj 2009
Date of renewal of authorisation: 15 May 2009.
Vend flasken og fjern sprøjten fra adaptoren.
Turn the bottle the right way up and remove the syringe from the adapter.
• hvis immunforsvaret er stærkt nedsat
• if their immune systems are very weak
Effekten og sikkerheden af disse terapier sammen med fosamprenavir og ritonavir er ikke klarlagt.
The efficacy and safety of these therapies with fosamprenavir and ritonavir has not been established.
Stigning i plasmakoncentrationen af quetiapin kan medføre koma.
Increased plasma concentrations of quetiapine may lead to coma.
Samtidig administration af amprenavir med grapefrugtjuice var ikke associeret med nogen klinisk signifikant ændring i plasma amprenavir farmakokinetikken.
Co-administration of amprenavir with grapefruit juice was not associated with clinically significant changes in plasma amprenavir pharmacokinetics.
Pædiatriske patienter (fra 6 år)
Paediatric patients (from 6 years of age)
Voksne med leversygdom
Adults with liver disease
Begge studier sammenlignede fosamprenavir/ritonavir med lopinavir/ritonavir.
Both of these studies compared fosamprenavir/ritonavir with lopinavir / ritonavir.
Telzir tabletter administreres oralt.
Telzir tablet is administered orally.
I så fald skal personen følges tæt
In this case close monitoring is required.
Ingen interaktionsstudier.
No drug interaction studies.