natgillin/translations-raw huggingface dataset:
• ciclosporin, rapamycin, tacrolimus (til undertrykkelse af immunforsvaret)
• cyclosporin, rapamycin, tacrolimus (used to suppress the immune system)
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).
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).
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).
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.
Hos rotter var der ingen væsentlig effekt på fertiliteten eller reproduktive præstation med fosamprenavir (se pkt.
In rats, there was no major effect on fertillty or reproductive performance with fosamprenavir (see section 5.3).
Osteonekrose: Særligt hos patienter med generelt anerkendte risikofaktorer, fremskreden hiv-sygdom eller i langvarig CART er der rapporteret om tilfælde af osteonekrose.
Osteonecrosis: cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to CART.
Anvendes med forsigtighed (se pkt.
Use with caution (see section 4.4).
Dosisjustering ikke nødvendig ved administration sammen med antacida, protonpumpehæmmere eller histamin-H2receptorantagonister.
No dosage adjustment necessary with antacids, proton-pump inhibitors or histamine H2 receptor antagonists.
Warfarin Andre orale antikoagulanter
Warfarin Other oral anticoagulants
Hiv-infektion spredes ved seksuel kontakt med en smittet person eller ved overførsel af inficeret blod (f.eks. hvis man deler nåle med andre).
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).
Hos patienter med hæmofili type A og B er der set øget blødning, mens de fik proteasehæmmere.
In patients with haemophilia type A and B, there have been reports of increased bleeding while taking protease inhibitors.
Når warfarin eller andre orale antikoagulanter administreres samtidig med Telzir anbefales en øget monitorering af INR (International Normaliseret Ratio) (se pkt.
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).
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.
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.
Øgede koncentrationer af HMGCoA-reduktasehæmmere kan forårsage myopati, herunder rabdomyolyse.
Increased concentrations of HMG-CoA reductase inhibitors may cause myopathy, including rhabdomyolysis.
Brug af anden medicin sammen med Telzir
Other medicines and Telzir
Ethinylestradiol 0,035 mg/norethisteron 0,5 mg én gang daglig
ORAL CONTRACEPTIVES Ethinyl estradiol 0.035 mg/norethisterone 0.5 mg once daily
Hos drægtige rotter og kaniner var der ingen større effekt på embryo-foster udviklingen, men antallet af aborter var forøget.
In pregnant rats and rabbits there were no major effects on embryo-foetal development.
Du vil blive fulgt tæt, hvis du tager følgende medicin sammen med Telzir/ritonavir:
You will be closely monitored if you are taking these medicines with Telzir/ritonavir:
Bør ikke anvendes samtidig medmindre den potentielle fordel ved behandlingen opvejer risikoen for systemiske bivirkninger forårsaget af kortikosteroider (se pkt.
Concomitant use is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects (see section 4.4).
Patienter med kronisk hepatitis B eller C behandlet med antiretroviral kombinationsbehandling har større risiko for alvorlige og potentielt fatale hepatiske bivirkninger.
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.
• halofantrin (mod malaria)
• halofantrine (used to treat malaria)
Yderligere dosisnedsættelse kan være nødvendig (se pkt.
Further dose reduction may be necessary (see section 4.5).
Patienter bør advares om disse mulige bivirkninger, når PDE5-hæmmere anvendes samtidig med Telzir/ritonavir (se pkt.
Patients should be warned about these possible side effects when using PDE5 inhibitors with Telzir/ritonavir (see section 4.4).
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).
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).
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.
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.
Lopinavir / ritonavir 533 mg/133 mg 2 gange daglig
Lopinavir / ritonavir 533 mg/133 mg twice daily
Tabel 2 Effektresultat ved uge 96 og uge 144 i studiet ESS100732 Extension (ART-naive patienter)
Table 2 Efficacy Outcome at Weeks 96 and 144 in ESS100732 Extension (ART-Naïve Patients)
Metaboliseringsen af amprenavir hæmmes af ritonavir via hæmning af CYP3A4, hvilket resulterer i en øget plasmakoncentration af amprenavir.
Amprenavir metabolism is inhibited by ritonavir, via inhibition of CYP3A4, resulting in increased plasma concentrations of amprenavir.
Pakningen er vedlagt en 10 ml doseringssprøjte, så dosis kan afmåles nøjagtigt.
A dosing syringe with a 10 ml graduation is supplied with the pack so you can measure your dose accurately.
Mere alvorlige bivirkninger såsom alvorlige udslæt og forhøjet hepatisk aminotransferase er også blevet rapporteret (se afsnittet "Beskrivelse af udvalgte bivirkninger").
More serious adverse reactions such as serious skin rashes and hepatic transaminase elevations have also been reported (cf paragraph Description of selected adverse reactions).
Ca. 14 % af den administrerede dosis findes som metabolitter i urinen, og ca. 75 % af den administrerede dosis findes som metabolitter i fæces.
Metabolites account for approximately 14 % of the administered amprenavir dose in the urine, and approximately 75 % in the faeces.
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.
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).
I mennesker omdannes fosamprenavir til amprenavir.
Fosamprenavir is converted in man to amprenavir.
Median ændring fra baseline i CD4-celler (celler/µl)
Median Change from baseline in CD4 cells (cells/µl)
• rifabutin doser på mere end 150 mg hver anden dag (et antibiotikum)
• doses of rifabutin greater than 150 mg every other day (an antibiotic)
Bivirkningsprofilen for Telzir skal tages i betragtning, når patientens evne til at føre motorkøretøj eller betjene maskiner vurderes (se pkt.
The adverse reaction profile of Telzir should be borne in mind when considering the patient's ability to drive or operate machinery (see section 4.8).
18 mg/kg (0,36 ml/kg); max. 700 mg eller 14 ml
18 mg/kg (0.36 ml/kg ); maximum 700 mg or 14 ml
Samtidig administration af Telzir med lavdosis ritonavir og disse lægemidler formodes at øge koncentrationerne af disse markant og kan resultere i PDE5-hæmmerassocierede bivirkninger, såsom hypotension, synsændringer og priapisme (se pkt.
Co-administration of Telzir with low dose ritonavir and these medicinal products is expected to substantially increase their concentrations and may result in PDE5 inhibitor-associated adverse events such as hypotension, visual changes and priapism (see section 4.5).
Hormonel prævention
Hormonal contraception
Hold sprøjtens spids mod indersiden af kinden og sprøjt dosis ind i munden.
Put the syringe into your mouth, placing the tip of the syringe against the inside of your cheek.
Abnorme laboratorieværdier: Abnorme laboratorieværdier (grad 3 eller 4) potentielt relateret til behandling med fosamprenavir og ritonavir, og rapporteret hos 1 % eller mere end 1 % af de voksne patienter, inkluderede: Forhøjet ALAT (almindelig), ASAT (almindelig), serumlipase (almindelig) og triglycerider (almindelig).
Clinical chemistry abnormalities: clinical chemistry abnormalities (Grade 3 or 4) potentially related to treatment with fosamprenavir with ritonavir and reported in greater than or equal to 1 % of adult patients, included: increased ALT (common), AST (common), serum lipase (common) and triglycerides (common).
Blandt de 81 PI-naive pædiatriske patienter behandlet med fosamprenavir/ritonavir, oplevede 15 patienter protokoldefineret virologisk svigt gennem 48 uger i APV29005 og op til 108 uger i APV20003.
Among the 81 PI-naïve paediatric patients treated with fosamprenavir / ritonavir, 15 patients met protocol-defined virological failure through 48 weeks in APV29005 and up to 108 weeks in APV20003.
Phenobarbital Carbamazepin
Phenobarbital Carbamazepine
Tilsvarende kan administration af fosamprenavir og ritonavir modificere farmakokinetikken af andre aktive substanser med denne metaboliseringsvej.
Similarily, administration of fosamprenavir with ritonavir may modify the pharmacokinetics of other active substances that share this metabolic pathway.
(Telzir 1.400 mg enkelt dosis)
(Telzir 1400 mg single dose)
Børn fra 6 år, som vejer mindre end 39 kg Tag Telzir som oral suspension.
Children from 6 years of age and weighing less than 39 kg Use Telzir oral suspension.
Samtidig administration af fosamprenavir/ritonavir med andre antineoplastiske midler metaboliseret af CYP3A (f.eks. dasatinib, nilotinib, ibrutinib, vinblastin og everolimus) kan øge koncentrationerne af disse lægemidler, hvilket potentielt øger risikoen for bivirkninger, der normalt er forbundet med disse midler.
Co-administration of fosamprenavir/ritonavir with other antineoplastics metabolised by CYP3A (for example dasatinib, nilotinib, ibrutinib, vinblastine and everolimus) may increase concentrations of these medicinal products, potentially increasing the risk of adverse events usually associated with these agents.
Immunreaktiveringssyndrom: Hos hiv-inficerede patienter med svær immuninsufficiens kan der ved påbegyndelse af antiretroviral kombinationsbehandling (CART) opstå en inflammatorisk reaktion på asymptomatiske eller residuale opportunistiske infektioner.
Immune Reactivation Syndrome: in HIV-infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
Titandioxid (E171) Glyceroltriacetat Rød jernoxid (E172)
Hypromellose Titanium dioxide (E171) Glycerol triacetate Iron oxide red (E172)
Ændring fra baseline i CD4celler (celler/µl)
Change from baseline in CD4 cells (cells/µl)
Autoimmune sygdomme (som f.eks. Graves´ sygdom og autoimmun hepatitis) er også blevet rapporteret i forbindelse med immunreaktivering; dog er den rapporterede tid til frembrud mere variabel, og frembrud kan forekomme mange måneder efter behandlingsstart.
Autoimmune disorders (such as Graves' disease) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and can occur many months after initiation of treatment.
Resultatet var til fordel for lopinavir/ritonavir armen som vist nedenfor.
Results were in favour of the lopinavir / ritonavir arm as detailed below.
Samtidig administration af det antipsykotiske lægemiddel lurasidon og fosamprenavir/ritonavir (FPV / RTV) er kontraindiceret (se pkt.
Co-administration of the antipsychotic medicinal product lurasidone and fosamprenavir/ritonavir (FPV/RTV) is contraindicated (see section 4.5).
Hvis du har spørgsmål til disse oplysninger:  Tal med lægen.
If you have any questions about this information or the advice given: →Talk to your doctor.
Nukleosid/Nukleotid revers transkriptasehæmmere:
Nucleoside / Nucleotide reverse transcriptase inhibitors:
Telzir kræver ingen særlige forholdsregler vedrørende opbevaringen.
Telzir does not require any special storage conditions.
En resistensmutation forekom i alle 3 isolater: henholdsvis K20K/R, I54I/L og I93I/L.
One resistance mutation was observed in each of 3 isolates: K20K/R, I54I/L and I93I/L respectively
Telzir oral suspension indeholder propyl- og methylparahydroxybenzoat.
The Telzir oral suspension contains propyl and methyl parahydroxybenzoate.
Idet doserne anvendt i reproduktionsstudierne var lave, er den potentielle udviklingstoksicitet af Telzir ikke fuldstændigt klarlagt.
In view of the low exposure in reproductive toxicity studies, the potential developmental toxicity of Telzir has not been fully determined.
Bivirkningerne havde som minimum moderat intensitet (grad 2 eller derover) hos mindst 1 % af patienterne og blev rapporteret af investigator som relateret til lægemidlet anvendt i studiet.
Most of the adverse reactions below were reported from three large clinical studies in adults, where the adverse events were of at least moderate intensity (Grade 2 or more) occurring in at least 1% of patients and reported by investigators as being attributable to the medicinal products used in the studies.
Fosamprenavir var ikke mutagent eller genotoksisk i en række genetiske toksicitetsprøver foretaget in vivo og in vitro.
Fosamprenavir was not mutagenic or genotoxic in a standard battery of in vitro and in vivo assays.
Ritonavir: Cmax  63 %* Ritonavir: AUC  45 %* * sammenlignet med historiske data
Ritonavir: Cmax ↑ 63%* Ritonavir: AUC ↑ 45%* * compared to historical data
Samtidig brug af Telzir med ritonavir og fluticason eller andre glukokortikoider, som metaboliseres af CYP3A4, frarådes, med mindre de potentielle fordele ved behandlingen opvejer risikoen for systemiske bivirkninger forårsaget af kortikosteroider, herunder Cushings syndrom og binyrebarksuppression (se pkt.
Concomitant use of Telzir with ritonavir and fluticasone or other glucocorticoids that are metabolised by CYP3A4 is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression (see section
• hvis du har en leversygdom.
• If you have liver disease.
Det skal du vide, før du begynder at tage Telzir
What you need to know before you take Telzir
Tabel 1 Effektresultat ved uge 48 i studiet ESS100732 (ART-naive patienter)
Table 1 Efficacy Outcome at Week 48 in ESS100732 (ART-Naïve Patients)
Samtidig anvendelse frarådes.
Concomitant use is not recommended.
Patienter med plasma hiv-1 RNA < 400 kopier/ml, snapshot analyse Median ændring fra baseline i CD4-celler (celler/μl), observeret analyse
Patients with plasma HIV-1 RNA <400 copies/ml, Snapshot analysis Median change from baseline in CD4 cells
Telzir kan ikke forhindre dig i at smitte.
Telzir will not stop you passing on HIV.
En klinisk signifikant stigning af levertransaminase forekom hos nogle personer.
Clinically significant hepatic transaminase elevations occurred in some subjects.
Der er ikke udført studier, hvor Telzir/ritonavir tages sammen med anden hormonbehandling såsom hormonerstatning.
No studies have been done on the use of Telzir/ritonavir with other hormonal therapies, such as hormone replacement therapy (HRT).
De hyppigst (> 5 % af behandlede voksne patienter) rapporterede bivirkninger med kombination af fosamprenavir/ritonavir var gastrointestinale reaktioner (kvalme, diarré, mavesmerter og opkastning) og hovedpine.
The most frequently (> 5% of adult subjects treated) reported adverse reactions with fosamprenavir/ritonavir combination were gastrointestinal reactions (nausea, diarrhoea, abdominal pain and vomiting) and headache.
Den kliniske erfaring med fosamprenavir boosted med ritonavir er hovedsageligt baseret på to åbne studier, et studie udført hos antiretroviral-naive patienter (studie ESS100732), samt et studie hos antiretroviral-erfarne patienter (studie APV30003).
Clinical experience with fosamprenavir boosted with ritonavir is mainly based on two open label studies, one in antiretroviral naïve patients (study ESS100732), and one study in antiretroviral experienced patients (study APV30003).
Antiviral aktivitet baseret på genotype/fænotype-resistens
Antiviral activity according to genotypic/phenotypic resistance
Forekomsten af de endometriale fund var en smule højere sammenlignet med kontrolgruppen, men inden for normalen (background range) for hunrotter.
The incidence of endometrial findings was slightly increased over concurrent controls, but within background range for female rats.
Dosisjustering vurderes unødvendig hos patienter med nedsat nyrefunktion (se pkt.
No dose adjustment is considered necessary in patients with renal impairment (see section 5.2).
Der kan ikke gives doseringsanbefalinger for meget unge børn (børn < 2 år), og Telzir i kombination med ritonavir bør ikke anvendes til denne patientgruppe (se pkt.
No dosing recommendations can be made for the very young (children < 2 years of age) and Telzir with ritonavir is not recommended for this patient population (see section 4.2).
Pædiatriske patienter bør tage den orale suspension med mad for at forbedre smag og komplians (se pkt.
In paediatric patients, the oral suspension should be taken with food in order to aid palatability and assist compliance (see section 5.2).
Reduktionen af (R-) methadon (aktiv enantiomer) forventes ikke at være klinisk signifikant, men for en sikkerheds skyld skal patienterne overvåges for abstinenser.
The decrease of (R-) methadone (active enantiomer) is not expected to be clinically significant.
Hos patienter, der tidligere er behandlet med proteasehæmmere (PI'er), bør valget af Telzir baseres på individuel testning af virusresistens og patientens tidligere behandling (se pkt.
In protease inhibitor (PI) experienced patients, the choice of Telzir should be based on individual viral resistance testing and treatment history (see section 5.1).
ANTACIDA, HISTAMINH2-RECEPTORANTAGONISTER OG PROTONPUMPEHÆMMERE
ANTACIDS, HISTAMINE H2 RECEPTOR ANTAGONIST AND PROTON-PUMP INHIBITORS
Der er ikke observeret klinisk signifikant interaktion.
No clinically significant interaction is observed.
Toksiciteten forekom ved plasmakoncentrationer, som var lavere end plasmakoncentrationen hos mennesker ved behandling med fosamprenavir i kombination med ritonavir ved den anbefalede dosis.
Toxicity was similar to that of amprenavir and occurred at amprenavir plasma exposure levels below human exposure after treatment with fosamprenavir in combination with ritonavir at the recommended dose.
Telzir i kombination med en lav dosis ritonavir anvendes sammen med anden antiretroviral medicin (”kombinationsbehandling”) til behandling af voksne, unge og børn fra 6 år, der har hiv.
Telzir with low doses of ritonavir is used in combination with other anti-retroviral medicines (‘combination therapy') to treat adults, adolescents and children aged over 6 years infected with HIV.
ETIKET TIL FLASKE TIL ORAL SUSPENSION
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL FOR ORAL SUSPENSION
Telzir skal anvendes i kombination med lave doser ritonavir og anden antiretroviral medicin.
Telzir is to be taken in combination with low doses of ritonavir and other antiretroviral medicines.
Telzir må ikke blandes med andre lægemidler, hverken i sprøjten eller i flasken.
Step by step instructions Do not mix Telzir with any other medicines in the bottle or the syringe.
Børn og unge bør tage Telzir oral suspension sammen med mad.
Children and adolescents should take the Telzir oral suspension with food.
Alvorlige proteasemutationer opstået under behandling eller APV-forbundede mutationer blev set i virus isoleret fra 1 patient i APV29005 og 6 patienter fra APV20003.
Treatment-emergent major protease or APV-associated mutations were observed in virus isolated from 1 patient in APV29005 and 6 patients from APV20003.
Tenofovirdisoproxil 245 mg én gang daglig
Tenofovir disoproxil 245 mg once daily
Telzir hører til i en gruppe af antiretroviral medicin, der kaldes proteasehæmmere.
Telzir belongs to a group of anti-retroviral medicines called protease inhibitors.
Lad sprøjte og adapter ligge, således at disse er helt tørre før de skal anvendes igen.
Let them dry completely before you use them again.
Se nedenstående tabel for doseringsanbefalinger til voksne.
Please refer to the table below for the dosing recommendations in adults.
Ingen FPV/RTV interaktionsstudier.
No FPV/RTV drug interaction studies.
Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinier.
Any unused medicinal product should be disposed of in accordance with local requirements.
I stedet for Telzir oral suspension:
As an alternative to taking Telzir oral suspension:
Telzir findes også som 700 mg filmovertrukne tabletter.
Telzir is also available as 700 mg film-coated tablets.
Sammenlignet med historiske data er eksponeringen af amprenavir uændret.
Amprenavir exposure unchanged when compared to historical data.
 Hold kontakt med lægen og stop ikke med at tage Telzir, før lægen anbefaler det.
→ Keep in touch with your doctor, and don't stop taking Telzir without your doctor's advice.
SELEKTIVE SEROTONINREUPTAKE-HÆMMERE (SSRI'er)
SELECTIVE SEROTONIN REUPTAKE INHIBITORS (SSRIS)
Amprenavir hæmmer endvidere CYP3A4-enzymet, dog i mindre omfang end ritonavir.
Amprenavir in addition is also an inhibitor of the CYP3A4 enzyme, although to a lesser extent than ritonavir.
• en kombination af lopinavir/ritonavir (mod hiv-infektion)
• lopinavir/ritonavir combination (used to treat HIV infection)
Magnesiumstearat Kolloid vandfri silica
Magnesium stearate Colloidal anhydrous silica
Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
Do not use this medicine after the expiry date which is stated on the carton and the bottle.
Den gennemsnitlige laveste steady state amprenavir-plasmakoncentration (Cmin) var 2,12 (1,772,54) g/ml, og AUC0-tau var 39,6 (34,5-45,3)h·g/ml.
The mean steady state plasma amprenavir trough concentration (Cmin) was 2.12 (1.77-2.54) µg/ml and AUC0-tau was 39.6 (34.5-45.3) h*µg/ml.
Tabel 3 Effektresultat ved uge 48 i APV30003 ITT(E)-populationen (patienter, der tidligere har fået antiviral behandling)
Table 3 Efficacy at Week 48 Outcomes in APV30003 ITT(E) Population (ART-experienced Patients)
Kontraindiceret (se pkt.
Contraindicated (see section