FrancophonIA/ELRC3.0 huggingface dataset:
English: Take special care with Telzir Talk to your doctor or pharmacist before taking Telzir:
Danish: Vær ekstra forsigtig med at tage Telzir Kontakt lægen eller apoteket, før du tager Telzir:
English: The rash generally will resolve spontaneously without the necessity of discontinuing treatment with the fosamprenavir with ritonavir.
Danish: Udslættene vil normalt forsvinde spontant uden nødvendig seponering af behandlingen med fosamprenavir og ritonavir.
English: Pharmacotherapeutic group: Antivirals for systemic use, protease inhibitor, ATC Code: J05AE07 Mechanism of action
Danish: Farmakoterapeutisk klassifikation: Antivirale midler; proteasehæmmer, ATC-kode: J05AE07.
English: By stopping protease from working, Telzir stops HIV multiplying and infecting more CD4 cells.
Danish: Ved at hindre protease i at virke, kan Telzir forhindre hiv i at formere sig og inficere flere CD4-celler.
English: Telzir is also available as a liquid (oral suspension) for people who are unable to swallow tablets.
Danish: Telzir fås også i en flydende udgave (oral suspension) til personer, der ikke kan sluge tabletter.
English: Glaxo Operations UK Ltd (trading as GlaxoWellcome Operations), Harmire Road, Barnard Castle, Co. Durham DL12 8DT, United Kingdom or
Danish: Glaxo Operations UK Ltd. (registreret som GlaxoWellcome Operations), Harmire Road, Barnard Castle, Co. Durham DL12 8DT, Storbritannien eller
English: Table 4 AAUCMB at Week 48 by genotypic sensitivity score in OBT and baseline resistance to FPV/RTV
Danish: Tabel 4 AAUCMB ved uge 48 ved genotypisk sensitivitetsscore i OBT og baseline resistens overfor FPV/RTV
English: Most adverse reactions associated with fosamprenavir/ritonavir combination therapies were mild to moderate in severity, early in onset and rarely treatment limiting.
Danish: De fleste bivirkninger i forbindelse med kombinationsbehandling med fosamprenavir/ritonavir var milde til moderate, tidligt indsættende og sjældent begrænsende for behandlingen.
English: Adverse reactions are listed by MedDRA system organ class and absolute frequency.
Danish: MedDRA-systemorganklasser og absolut frekvens.
English: In case of withdrawal of glucocorticoids, progressive dose reduction may have to be performed over a longer period (see section 4.4).
Danish: Ved behandlingsophør med glukokortikoider skal nedtrapningen ske gradvist over en længere periode (se pkt.
English: If you have taken more than the prescribed dose of Telzir: →Contact your doctor or pharmacist immediately for advice.
Danish: Hvis du har taget for meget Telzir Hvis du har taget mere end den ordinerede dosis af Telzir:  Kontakt straks lægen eller apoteket for rådgivning.
English: Rash / cutaneous reactions: erythematous or maculopapular cutaneous eruptions, with or without pruritus, may occur during therapy.
Danish: Udslæt/hudreaktioner: Erytematøse eller makulopapulære kutane eruptioner med eller uden pruritus kan forekomme under behandlingen.
English: ViiV Healthcare Trading Services UK Limited, 12 Riverwalk, Citywest Business Campus Dublin 24, Ireland
Danish: ViiV Healthcare Trading Services UK Limited, 12 Riverwalk, Citywest Business Campus Dublin 24, Irland
English: Subjects with >1 log10 change from baseline in plasma HIV1 RNA
Danish: Patienter med > 1 log10 ændring fra baseline i plasma-hiv-1RNA
English: See section ‘Other medicines and Telzir'.
Danish: Se afsnittet ”Brug af anden medicin sammen med Telzir”.
English: Ritonavir dose (TWICE DAILY)
Danish: Ritonavir dosis (2 GANGE DAGLIG)
English: Amprenavir appears to penetrate into semen, though semen concentrations are lower than plasma concentrations.
Danish: Amprenavir kan findes inde i sæd, men koncentrationen fundet i sæd er lavere end koncentrationen i plasma.
English: It is therefore important that you carefully read the package leaflet provided with these medicines.
Danish: Det er derfor vigtigt, at du også omhyggeligt læser indlægssedlen til al anden medicin, du får.
English: The pack also includes a polyethylene syringe-adapter and a 10 ml oral dosing syringe comprised of a polypropylene barrel (with ml graduations) and a polyethylene plunger.
Danish: Pakningen indeholder desuden en adapter af polyethylen samt en 10 ml doseringssprøjte bestående af en cylinder af polypropylen (med angivelse af ml) og et stempel af polyethylen.
English: • carbamazepine, phenobarbital, phenytoin (used to treat epilepsy)
Danish: • carbamazepin, phenobarbital, phenytoin (mod epilepsi)
English: Headache, dizziness, oral paraesthesia
Danish: Hovedpine, svimmelhed, oral paræstesi
English: Single 30 ml dose of antacid suspension (equivalent to 3.6 grams aluminium hydroxide and 1.8 grams magnesium hydroxide
Danish: Enkeltdosis (30 ml) af antacidasuspension (ækvivalent med 3,6 gram aluminiumhydroxid og 1,8 gram magnesiumhydroxid)
English: Concomitant administration of fosamprenavir /ritonavir with lurasidone is contraindicated due to the potential for serious and/or life-threatening reactions related to lurasidone (see section 4.3)
Danish: Samtidig administration af fosamprenavir/ ritonavir med lurasidon er kontraindiceret på grund af risikoen for alvorlige og/eller livstruende reaktioner relateret til lurasidon (se pkt.
English: Oral suspension should be taken with food
Danish: Den orale suspension bør tages med mad
English: Renal clearance of ritonavir is also negligible, therefore the impact of renal impairment on amprenavir and ritonavir elimination should be minimal
Danish: Nyrernes udskillelse af ritonavir er ligeledes forsvindende lille, og derfor vurderes betydningen af nedsat nyrefunktion på eliminationen af amprenavir og ritonavir til at være minimal.
English: ITT-E observed analysis
Danish: ITT-E observeret analyse
English: There are insufficient data to recommend the use of fosamprenavir with ritonavir in heavily pre-treated patients.
Danish: Der foreligger ikke tilstrækkelige data til at anbefale behandling med fosamprenavir og ritonavir til svært behandlingserfarne patienter.
English: Telzir tablets can be taken with or without food.
Danish: Telzir tabletter kan tages med eller uden mad.
English: In reproductive toxicity studies with fosamprenavir in rats, male fertility was not affected.
Danish: I reproduktive toksikologiske studier af fosamprenavir i rotter var fertiliteten hos hanrotterne upåvirket.
English: Examples of antineoplastic agents: dasatinib nilotinib ibrutinib vinblastine everolimus
Danish: Eksempler på antineoplastiske midler: dasatinib nilotinib ibrutinib vinblastin everolimus
English: ITT-E Population TLOVR analysis
Danish: ITT-E population TLOVR analyse
English: There have been reports of muscle pain, tenderness or weakness, particularly with antiretroviral therapy including protease inhibitors and nucleoside analogues.
Danish: Der er set tilfælde af muskelsmerter, ømhed eller svækkelse, især ved antiretroviral behandling med både proteasehæmmere og nukleosidanaloger.
English: • if they are also taking anti-inflammatory medicines called corticosteroids
Danish: • hvis man også tager medicin af typen kortikosteroider mod betændelseslignende tilstande
English: There have been reports of increased bleeding including spontaneous skin haematomas and haemarthroses in haemophiliac patients type A and B treated with protease inhibitors (PIs).
Danish: Der er rapporteret om øget blødningstendens, herunder spontane hudhæmatomer og hæmarthroner, hos hæmofilipatienter type A og B, som blev behandlet med proteasehæmmere (PI'er).
English: ANTIHISTAMINES (HISTAMINE H1 RECEPTOR ANTAGONISTS) Astemizole Terfenadine
Danish: ANTIHISTAMINER (HISTAMIN H1ANTAGONISTER) Astemizol
English: Oral suspension should be taken without food
Danish: Den orale suspension bør tages uden mad
English: Fluticasone propionate 50 µg intranasal 4 times daily) for 7 days
Danish: Fluticasonpropionat 50 µg intranasalt 4 gange daglig i 7 dage
English: • , , simeprevir, daclatasvir (used to treat hepatitis C virus infection)
Danish: • simeprevir, daclatasvir (mod hepatitis C-virusinfektion)
English: → Don't drive or operate machinery unless you're feeling well.
Danish:  Før kun motorkøretøj og betjen kun maskiner, hvis du har det godt.
English: HIV infection is spread by sexual contact with someone who has the infection, or by transfer of infected blood (for example, by sharing injection needles).
Danish: Hiv-infektion spredes ved seksuel kontakt med en smittet person eller ved overførsel af inficeret blod (f.eks. ved at dele injektionsnåle med andre).
English: In rabbits, systemic exposure at the high dose level was only 0.3 times human exposure at the maximum clinical dose and thus the development toxicity of fosamprenavir has not been fully determined.
Danish: Hos kaniner var den systemiske eksponering af den højeste dosis kun 0,3 gange den dosis for human eksponering ved maksimum klinisk dosis og derfor er den udviklingsrelaterede toksicitet af fosamprenavir ikke klarlagt.
English: Telzir suspension is administered orally.
Danish: Telzir suspension administreres oralt.
English: Because there may be an increased risk of hepatic transaminase elevations and hormonal levels may be altered with co-administration of fosamprenavir, ritonavir and oral contraceptives, alternative nonhormonal methods of contraception are recommended for women of childbearing potential (see section 4.5).
Danish: Da der kan være øget risiko for levertransaminase stigninger og niveauet af hormoner kan være ændret ved samtidig administration af fosamprenavir, ritonavir og orale præventionsmidler, anbefales alternative ikke-hormonale præventionsmidler til fertile kvinder (se pkt.
English: Atorvastatin 10 mg once daily for 4 days
Danish: Atorvastatin 10 mg én gang daglig i 4 dage
English: No data are available on the co-administration of fosamprenavir and ritonavir with oestrogens and/or progestogens when used as hormonal replacement therapies.
Danish: Der foreligger ingen data for samtidig administration af fosamprenavir og ritonavir med østrogen og/eller progesteron, når disse anvendes som erstatningsterapi.
English: Repeat dose studies with fosamprenavir in rats produced effects consistent with hepatic enzyme induction, which predisposes rats to thyroid neoplasms.
Danish: Studier med rotter, der fik gentagne doser af fosamprenavir, viste påvirkninger forenelig med enzyminduktion i leveren, hvilket prædisponerer rotter for thyroide neoplasmaer.
English: In case of concomitant administration with antineoplastic agents metabolized by CYP3A, please refer to the relevant product information for these medications.
Danish: I tilfælde af samtidig administration med antineoplastiske midler, der metaboliseres af CYP3A, henvises til de relevante produktresuméer for disse lægemidler.
English: Rarely, the skin rash can be severe and serious (Stevens Johnson syndrome).
Danish: I sjældne tilfælde kan udslættet blive voldsomt og alvorligt (Stevens-Johnsons syndrom).
English: No clinically significant interaction is expected.
Danish: Der forventes ikke klinisk signifikant interaktion.
English: If you notice any muscle problems: →Tell your doctor.
Danish: Hvis du får muskelproblemer:  Fortæl det til lægen.
English: Children from 6 years of age and weighing at least 25 kg Children should take the Telzir oral suspension with food.
Danish: Børn fra 6 år, som vejer mindst 25 kg Børn skal tage Telzir oral suspension sammen med mad.
English: The suspension is white to off-white in colour.
Danish: Suspensionens farve er hvid til off-white.
English: It is recommended that HIV-infected women must not breast-feed under any circumstances to avoid transmission of HIV.
Danish: For at undgå overførsel af hiv anbefales det, at hiv-inficerede kvinder under ingen omstændigheder ammer deres børn.
English: Telzir does not require any other special storage conditions.
Danish: Telzir kræver ikke andre særlige forholdsregler vedrørende opbevaringen.
English: Amprenavir binds to the active site of HIV-1 protease and thereby prevents the processing of viral gag and gag-pol polyprotein precursors, resulting in the formation of immature non-infectious viral particles.
Danish: Amprenavir bindes til det aktive site på hiv-1-proteasen og forebygger dermed spaltningen af viral gag og gag-pol polyprotein forstadier, så der dannes umodne, ikke-infektiøse viruspartikler.
English: • If you have diabetes.
Danish: • hvis du har sukkersyge.
English: Please refer to the relevant product information for these medications (see section 4.5).
Danish: Der henvises til de relevante produktresuméer for disse lægemidler (se pkt.
English: ITT (Ext) Observed analysis
Danish: ITT (Ext) Observeret analyse
English: Co-administration of paritaprevir and fosamprenavir/ritonavir (FPV/RTV) is contraindicated due to the expected increase of paritaprevir exposure and the lack of clinical data assessing the magnitude of this increase (see section 4.5).
Danish: Samtidig administration af paritaprevir og fosamprenavir/ritonavir (FPV/RTV) er kontraindiceret pga. den forventede stigning i eksponeringen for paritaprevir og manglen på kliniske data til vurdering af størrelsen af denne stigning (se pkt.
English: • doses of ketoconazole and itraconazole greater than 200 mg per day (used to treat fungal infections)
Danish: • ketoconazol og itraconazol doser på mere end 200 mg om dagen (mod svampeinfektioner)
English: A 75 % reduction of the standard rifabutin dose (i.e. to 150 mg every other day) is recommended.
Danish: En 75 % reduktion af rifabutinstandarddosis anbefales (dvs. til 150 mg hver anden dag), Yderligere dosisreduktion kan være nødvendig (se pkt.
English: Aspen Bad Oldesloe GmbH, Industriestrasse 32-36, D-23843, Bad Oldesloe, Germany or
Danish: Oral suspension Aspen Bad Oldesloe GmbH, Industriestrasse 32-36, D-23843, Bad Oldesloe, Tyskland.
English: If the submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
Danish: Når tidsfristen for fremsendelse af en periodisk, opdateret sikkerhedsindberetning (PSUR) er sammenfaldende med tidsfristen for opdatering af en RMP, skal de fremsendes samtidig.
English: The conversion of fosamprenavir to amprenavir appears to primarily occur in the gut epithelium.
Danish: Omdannelsen af fosamprenavir til amprenavir syntes primært at foregå i tarmens epitel.
English: Telzir with ritonavir is not recommended in children below 6 years due to insufficient data on pharmacokinetics, safety and antiviral response (see section 5.2).
Danish: Telzir i kombination med ritonavir bør ikke anvendes til børn under 6 år pga. utilstrækkelige data om farmakokinetik, sikkerhed og antiviralt respons (se pkt.
English: Important information about ingredients of Telzir oral suspension Telzir oral suspension contains propyl and methyl parahydroxybenzoate.
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Telzir oral suspension Telzir oral suspension indeholder propyl- og metylparahydroxybenzoat.
English: In the Time to loss of virological response (TLOVR) analysis for the ITT(E) population, the proportion of patients achieving <400 copies/ml was 73 % (315 / 434) in the fosamprenavir with ritonavir group compared to 71 % (317 / 444) of patients receiving lopinavir / ritonavir, with a 95 % confidence interval of the difference of [-4,84%; 7;05%].
Danish: Ved tiden til tab af virologisk respons (TLOVR) analyse af ITT(E) gruppen, var andelen af patienter der opnåede < 400 kopier/ml 73 % (315/434) i fosamprenavir med ritonavir gruppen, sammenlignet med 71 % (317/444) hos patienterne der modtog lopinavir/ritonavir, med et 95 % konfidensinterval med en forskel på [-4,84 %; 7,05 %].
English: • cyclosporin, rapamycin, tacrolimus (used to suppress the immune system)
Danish: • ciclosporin, rapamycin, tacrolimus (til undertrykkelse af immunforsvaret)
English: Non-inferiority was demonstrated between fosamprenavir co-administered with ritonavir and lopinavir / ritonavir based on the proportions of patients achieving plasma HIV-1 RNA levels < 400 copies/ml at 48 weeks (primary endpoint).
Danish: Non-inferioritet blev demonstreret mellem fosamprenavir sammen med ritonavir og lopinavir/ritonavir baseret på den andel af patienter, der opnåede plasma hiv-1-RNA niveauer < 400 kopier/ml ved 48 uger (primære endepunkt).
English: A dose reduction of the glucocorticoid with close monitoring of local and systemic effects or a switch to a glucocorticoid, which is not a substrate for CYP3A4 (e.g. beclomethasone) should be considered.
Danish: Dosisreduktion af glukokortikoidet og tæt monitorering for lokale og systemiske bivirkninger bør overvejes, alternativt at skifte til et glukokortikoid, som ikke er substrat for CYP3A4 (for eksempel beclometason).
English: In rats, there was no major effect on fertillty or reproductive performance with fosamprenavir (see section 5.3).
Danish: Hos rotter var der ingen væsentlig effekt på fertiliteten eller reproduktive præstation med fosamprenavir (se pkt.
English: Osteonecrosis: cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to CART.
Danish: Osteonekrose: Særligt hos patienter med generelt anerkendte risikofaktorer, fremskreden hiv-sygdom eller i langvarig CART er der rapporteret om tilfælde af osteonekrose.
English: Use with caution (see section 4.4).
Danish: Anvendes med forsigtighed (se pkt.
English: No dosage adjustment necessary with antacids, proton-pump inhibitors or histamine H2 receptor antagonists.
Danish: Dosisjustering ikke nødvendig ved administration sammen med antacida, protonpumpehæmmere eller histamin-H2receptorantagonister.
English: Warfarin Other oral anticoagulants
Danish: Warfarin Andre orale antikoagulanter
English: HIV infection is spread by sexual contact with someone who's got the infection, or by transfer of infected blood (for example by sharing needles).
Danish: Hiv-infektion spredes ved seksuel kontakt med en smittet person eller ved overførsel af inficeret blod (f.eks. hvis man deler nåle med andre).
English: In patients with haemophilia type A and B, there have been reports of increased bleeding while taking protease inhibitors.
Danish: Hos patienter med hæmofili type A og B er der set øget blødning, mens de fik proteasehæmmere.
English: When warfarin or other oral anticoagulants are co-administered with Telzir a reinforced monitoring of INR (International normalised ratio) is recommended (see section 4.5).
Danish: Når warfarin eller andre orale antikoagulanter administreres samtidig med Telzir anbefales en øget monitorering af INR (International Normaliseret Ratio) (se pkt.
English: No new safety concerns were identified from analyses of 48 week data from studies APV29005 or APV20002, in which 54 subjects 4 weeks to <2 years of age received twice daily fosamprenavir / ritonavir with background nucleoside reverse transcriptase inhibitor therapy and 5 subjects received only single doses of fosamprenavir with or without ritonavir.
Danish: Ingen nye sikkerhedsanliggender blev identificeret efter analyse af 48 ugers data fra studierne APV29005 eller APV20002, hvor 54 patienter i alderen 4 uger til < 2 år fik fosamprenavir/ritonavir 2 gange daglig samt bagvedliggende behandling med nukleosid revers transkriptasehæmmere og 5 patienter fik kun enkeltdoser af fosamprenavir med eller uden ritonavir.
English: Increased concentrations of HMG-CoA reductase inhibitors may cause myopathy, including rhabdomyolysis.
Danish: Øgede koncentrationer af HMGCoA-reduktasehæmmere kan forårsage myopati, herunder rabdomyolyse.
English: Other medicines and Telzir
Danish: Brug af anden medicin sammen med Telzir
English: ORAL CONTRACEPTIVES Ethinyl estradiol 0.035 mg/norethisterone 0.5 mg once daily
Danish: Ethinylestradiol 0,035 mg/norethisteron 0,5 mg én gang daglig
English: In pregnant rats and rabbits there were no major effects on embryo-foetal development.
Danish: Hos drægtige rotter og kaniner var der ingen større effekt på embryo-foster udviklingen, men antallet af aborter var forøget.
English: You will be closely monitored if you are taking these medicines with Telzir/ritonavir:
Danish: Du vil blive fulgt tæt, hvis du tager følgende medicin sammen med Telzir/ritonavir:
English: Concomitant use is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects (see section 4.4).
Danish: Bør ikke anvendes samtidig medmindre den potentielle fordel ved behandlingen opvejer risikoen for systemiske bivirkninger forårsaget af kortikosteroider (se pkt.
English: Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk of severe and potentially fatal hepatic adverse reactions.
Danish: Patienter med kronisk hepatitis B eller C behandlet med antiretroviral kombinationsbehandling har større risiko for alvorlige og potentielt fatale hepatiske bivirkninger.
English: • halofantrine (used to treat malaria)
Danish: • halofantrin (mod malaria)
English: Further dose reduction may be necessary (see section 4.5).
Danish: Yderligere dosisnedsættelse kan være nødvendig (se pkt.
English: Patients should be warned about these possible side effects when using PDE5 inhibitors with Telzir/ritonavir (see section 4.4).
Danish: Patienter bør advares om disse mulige bivirkninger, når PDE5-hæmmere anvendes samtidig med Telzir/ritonavir (se pkt.
English: In repeated dose toxicity studies in adult rats and dogs, fosamprenavir produced evidence of gastrointestinal disturbances (salivation, vomiting and soft to liquid faeces), and hepatic changes (increased liver weights, raised serum liver enzyme activities and microscopic changes, including hepatocyte necrosis).
Danish: Ved gentagne dosistoksicitetsstudier med både voksne rotter og hunde har man for fosamprenavir påvist gastrointestinale forstyrrelser (spytafsondring, opkast og blød til flydende fæces) og ændringer i leveren (øget levervægt, øget serumleverenzymaktivitet, og mikroskopiske ændringer, herunder hepatocyt nekrose).
English: Co-administration of ritonavir with fosamprenavir increase plasma amprenavir AUC by approximately 2-fold and plasma Cτ,ss by 4- to 6-fold, compared to values obtained when fosamprenavir is administered alone.
Danish: Samtidig administration af ritonavir og fosamprenavir øger plasma-AUC for amprenavir ca. 2 gange og plasma-C,ss 4 til 6 gange, sammenlignet med registrerede værdier, når fosamprenavir administreres alene.
English: Lopinavir / ritonavir 533 mg/133 mg twice daily
Danish: Lopinavir / ritonavir 533 mg/133 mg 2 gange daglig
English: Table 2 Efficacy Outcome at Weeks 96 and 144 in ESS100732 Extension (ART-Naïve Patients)
Danish: Tabel 2 Effektresultat ved uge 96 og uge 144 i studiet ESS100732 Extension (ART-naive patienter)
English: Amprenavir metabolism is inhibited by ritonavir, via inhibition of CYP3A4, resulting in increased plasma concentrations of amprenavir.
Danish: Metaboliseringsen af amprenavir hæmmes af ritonavir via hæmning af CYP3A4, hvilket resulterer i en øget plasmakoncentration af amprenavir.
English: A dosing syringe with a 10 ml graduation is supplied with the pack so you can measure your dose accurately.
Danish: Pakningen er vedlagt en 10 ml doseringssprøjte, så dosis kan afmåles nøjagtigt.
English: More serious adverse reactions such as serious skin rashes and hepatic transaminase elevations have also been reported (cf paragraph Description of selected adverse reactions).
Danish: Mere alvorlige bivirkninger såsom alvorlige udslæt og forhøjet hepatisk aminotransferase er også blevet rapporteret (se afsnittet "Beskrivelse af udvalgte bivirkninger").
English: Metabolites account for approximately 14 % of the administered amprenavir dose in the urine, and approximately 75 % in the faeces.
Danish: Ca. 14 % af den administrerede dosis findes som metabolitter i urinen, og ca. 75 % af den administrerede dosis findes som metabolitter i fæces.
English: PDE5 inhibitors used for the treatment of erectile dysfunction: The use of Telzir concomitantly with PDE5 inhibitors (e.g. sildenafil, tadalafil, vardenafil) is not recommended (see section 4.5).
Danish: PDE5-hæmmere til behandling af erektil dysfunktion: Brug af Telzir sammen med PDE5-hæmmere (f.eks. sildenafil, tadalafil og vardenafil) kan ikke anbefales (se pkt.
English: Fosamprenavir is converted in man to amprenavir.
Danish: I mennesker omdannes fosamprenavir til amprenavir.