natgillin/translations-raw huggingface dataset:
Telzir i kombination med en lav dosis ritonavir er indiceret til behandling af HIV- 1- inficerede voksne, unge og børn over 6 år i kombination med andre antiretrovirale lægemidler.
Telzir in combination with low dose ritonavir is indicated for the treatment of Human Immunodeficiency Virus Type 1 (HIV-1) infected adults, adolescents and children of 6 years and above in combination with other antiretroviral medicinal products.
Hos voksne, der tidligere er blevet behandlet med antiretrovirale midler, har Telzir i kombination med en lav dosis ritonavir ikke vist sig så effektivt som lopinavir/ ritonavir.
In moderately antiretroviral experienced adults, Telzir in combination with low dose ritonavir has not been shown to be as effective as lopinavir / ritonavir.
Hos patienter, der har fået Telzir i en længere periode, er Telzir i kombination med en lav dosis ritonavir ikke tilstrækkeligt undersøgt.
In heavily pretreated patients the use of Telzir in combination with low dose ritonavir has not been sufficiently studied.
5. 1).
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).
Ritonavir virker som farmakokinetisk enhancer af amprenavir.
Telzir must only be given with low dose ritonavir as a pharmacokinetic enhancer of amprenavir and in combination with other antiretroviral medicinal products.
Telzir (fosamprenavir) er et prodrug af amprenavir og må ikke administreres samtidig med andre lægemidler indeholdende amprenavir.
Telzir (fosamprenavir) is a pro-drug of amprenavir and must not be administered concomitantly with other medicinal products containing amprenavir.
4. 4).
2 Caution is advised if the recommended doses of Telzir with ritonavir detailed below are exceeded (see section 4.4).
2 Telzir tabletter kan tages med eller uden mad.
Telzir tablet can be taken with or without food.
Børn under 6 år:
Children less than 6 years of age:
5. 2).
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).
5. 2).
The pharmacokinetics of fosamprenavir have not been studied in this patient population (see section 5.2).
5. 2).
No initial dose adjustment is considered necessary in patients with renal impairment (see section 5.2).
Til voksne med let nedsat leverfunktion (Child- Pugh Score:
For adults with mild hepatic impairment (Child-Pugh score:
5- 6) er den anbefalede dosis 700 mg fosamprenavir to gange daglig i kombination med 100 mg ritonavir en gang daglig.
5-6) the recommended dose is 700 mg fosamprenavir twice daily with 100 mg ritonavir once daily.
Til voksne med moderat nedsat leverfunktion (Child- Pugh Score:
For adults with moderate hepatic impairment (Child-Pugh score:
7- 9) er den anbefalede dosis 450 mg fosamprenavir to gange daglig i kombination med 100 mg ritonavir en gang daglig.
7-9) the recommended dose is 450 mg fosamprenavir twice daily with 100 mg ritonavir once daily.
Til voksne med svært nedsat leverfunktion (Child- Pugh Score:
For adults with severe hepatic impairment (Child-Pugh score:
10- 15) bør fosamprenavir anvendes med forsigtighed og i reduceret dosis på 300 mg fosamprenavir to gange daglig i kombination med 100 mg ritonavir en gang daglig.
10-15): fosamprenavir should be used with caution and at a reduced dose of 300 mg fosamprenavir twice daily with 100 mg ritonavir once daily.
Derfor er tæt monitorering af sikkerhed og virologisk respons påkrævet.
Even with these dose adjustments for adults, some patients with hepatic impairment may have higher or lower than anticipated amprenavir and/ or ritonavir plasma concentrations as compared to patients with normal hepatic function, due to increased inter-patient variability (see section 5.2), therefore a close monitoring of safety and virologic response is warranted.
Der kan ikke gives doseringsanbefalinger til børn og unge med nedsat leverfunktion, da der ikke er udført studier med disse aldersgrupper.
3 No dose recommendation can be made for children and adolescents with hepatic impairment as no studies have been conducted in these age groups.
Overfølsomhed over for fosamprenavir, amprenavir, et eller flere af hjælpestofferne eller for ritonavir.
Hypersensitivity to fosamprenavir, amprenavir or to any of the excipients of Telzir, or to ritonavir.
Telzir må ikke administreres samtidig med præparater, som har smalt terapeutisk vindue, og som er substrater for cytokrom P450 3A4 (CYP3A4), f. eks. amiodaron, astemizol, bepridil, cisaprid,
Telzir must not be administered concurrently with medicinal products with narrow therapeutic windows that are substrates of cytochrome P450 3A4 (CYP3A4), e. g. amiodarone, astemizole, bepridil, cisapride, dihydroergotamine, ergotamine, pimozide, quinidine, terfenadine, oral midazolam (for caution on parenterally administered midazolam, see section 4.5), oral triazolam.
4. 5).
Telzir with ritonavir must not be co-administered with medicinal products with narrow therapeutic windows that are highly dependent on CYP2D6 metabolism, e. g. flecainide and propafenone (see section 4.5).
Samtidig behandling med Telzir og lavdosis ritonavir i kombination med rifampicin er kontraindiceret (se pkt.
Combination of rifampicin with Telzir with concomitant low-dose ritonavir is contraindicated.
4. 5).
Herbal preparations containing St John’ s wort (Hypericum perforatum) must not be used while taking Telzir due to the risk of decreased plasma concentrations and reduced clinical effects of amprenavir (see section 4.5).
Patienterne kan fortsat udvikle opportunistiske infektioner eller andre komplikationer af HIV- infektionen.
Patients should be advised that treatment with Telzir, or any other current antiretroviral therapy, does not cure HIV and that they may still develop opportunistic infections and other complications of HIV infection.
Det er ikke påvist, at nuværende antiretroviral behandling, herunder Telzir, forebygger risikoen for at overføre HIV til andre gennem seksuel kontakt eller gennem smittet blod.
Current antiretroviral therapies, including Telzir, have not been proven to prevent the risk of transmission of HIV to others through sexual contact or blood contamination.
Risikoen for krydsoverfølsomhed mellem lægemidler i sul - fonamidgruppen og fosamprenavir er ukendt.
The potential for cross-sensitivity between medicinal products in the sulphonamide class and fosamprenavir is unknown.
Patienter med kronisk hepatitis B eller C behandlet med antiretroviral kombinationsbehandling har større risiko for alvorlige og potentielt fatale leverpåvirkninger.
Telzir with ritonavir should be used with caution and at reduced doses in adults with mild, moderate, or severe hepatic impairment (see section 4.2. 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 events.
Ved samtidig behandling af hepatitis B eller C med antivirale midler henvises til produktresumeet for disse produkter.
In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant Summary of Product Characteristics for these medicinal products.
Hos patienter med leverinsufficiens, herunder kronisk aktiv hepatitis, ses oftere abnorm leverfunktion i forbindelse med den antiretrovirale behandling, og disse patienter bør kontrolleres i henhold til standardpraksis.
Patients with pre-existing liver dysfunction, including chronic active hepatitis, have an increased frequency of liver function abnormalities during combination antiretroviral therapy and should be
4. 5).
The use of Telzir concomitantly with halofantrine or lidocaine (systemic) is not recommended (see section 4.5).
4. 5).
The use of Telzir concomitantly with PDE5 inhibitors (e. g. sildenafil and vardenafil) is not recommended (see section 4.5).
4. 5).
Concomitant use of Telzir with simvastatin or lovastatin is not recommended due to an increased risk of myopathy, including rhabdomyolysis (see section 4.5).
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.
4. 5).
Further dose reduction may be necessary (see section 4.5).
4. 5).
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 non- hormonal methods of contraception are recommended for women of childbearing potential (see section 4.5).
Der foreligger ingen data for samtidig administration af fosamprenavir og ritonavir med østrogen og/ eller progesteron, når disse anvendes som erstatningsterapi.
No data are available on the co-administration of fosamprenavir and ritonavir with oestrogens and/ or progestogens when used as hormonal replacement therapies.
4. 5).
Telzir may be less effective due to decreased amprenavir plasma concentrations in patients taking these medicinal products concomitantly (see section 4.5).
4. 5).
Therapeutic concentration monitoring is recommended for tricyclic antidepressants (e. g. desipramine and nortriptyline) when coadministered with Telzir (see section 4.5).
4. 5).
When warfarin or other oral anticoagulants are coadministered with Telzir a reinforced monitoring of INR (International Normalised Ratio) is recommended (see section 4.5).
4. 5).
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 4.5).
De fleste patienter med mildt eller moderat udslæt kan fortsætte med Telzir.
Most patients with mild or moderate rash can continue Telzir.
Sværere og livstruende hudreaktioner, herunder Stevens- Johnson syndrom, blev rapporteret hos mindre end 1 procent 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.
4. 8).
Telzir should be permanently discontinued in case of severe rash, or in case of rash of moderate intensity with systemic or mucosal symptoms (see section 4.8).
Der er rapporteret om øget blødningstendens, herunder spontane hudhæmatomer og hæmarthroner, hos hæmofilipatienter type A og B, som blev behandlet med proteasehæmmere (PI’ er).
In some
Hos nogle patienter var administration af faktor VIII nødvendig.
5 patients administration of factor VIII was necessary.
Nye tilfælde af diabetes mellitus, hyperglykæmi eller forværring af eksisterende diabetes mellitus er konstateret hos patienter behandlet med antiretroviral terapi, herunder proteasehæmmere.
New onset of diabetes mellitus, hyperglycaemia or exacerbations of existing diabetes mellitus have been reported in patients receiving antiretroviral therapy, including protease inhibitors.
Hos nogle af disse patienter var hyperglykæmien alvorlig og i visse tilfælde også ledsaget af ketoacidose.
In some of these, the hyperglycaemia was severe and in some cases also associated with ketoacidosis.
Hos mange af patienterne var der flere medicinske tilstande tilstede, heraf nogle som krævede behandling med midler, der er forbundet med udvikling af diabetes mellitus eller hyperglykæmi.
Many of the patients had confounding medical conditions, some of which required therapy with medicinal products that have been associated with the development of diabetes mellitus or hyperglycaemia.
Kendskabet til virknings - mekanismen er ufuldstændig.
Knowledge about the mechanism is incomplete.
Det er antaget, at der er en forbindelse mellem visceral lipomatose og proteasehæmmere samt lipoatrofi og nucleosid revers transkriptasehæmmere.
A connection between visceral lipomatosis and protease inhibitors and lipoatrophy and nucleoside reverse transcriptase inhibitors has been hypothesised.
5 relaterede faktorer såsom længere antiretroviral behandlingstid og ledsagende metaboliske forstyrrelser.
A higher risk of lipodystrophy has been associated with individual factors such as older age, and with drug related factors such as longer duration of antiretroviral treatment and associated metabolic disturbances.
Objektiv undersøgelse bør inkludere evaluering af fysiske tegn på omfordeling af fedt.
Clinical examination should include evaluation for physical signs of fat redistribution.
Når fosamprenavir og ritonavir administreres samtidig vil ritonavirs metaboliske interaktion tilsyneladende dominere, idet ritonavir er en mere potent CYP3A4- hæmmer.
When fosamprenavir and ritonavir are co-administered, the ritonavir metabolic drug interaction profile may predominate because ritonavir is a more potent CYP3A4 inhibitor.
Den fulde information for ritonavir skal derfor læses før påbegyndelse af kombinationsterapi med Telzir og ritonavir.
The full prescribing information for ritonavir must therefore be consulted prior to initiation of therapy with Telzir with ritonavir.
Ritonavir inducerer CYP3A4, CYP1A2, CYP2C9 og glucoronosyl transferase.
Ritonavir induces CYP3A4, CYP1A2, CYP2C9 and glucuronosyl transferase.
Derfor kan lægemidler, som har samme metaboliseringsvej eller modificerer aktiviteten af CYP3A4, muligvis ændre farmakokinetikken af amprenavir og ritonavir.
6 metabolic pathway or modify CYP3A4 activity may modify the pharmacokinetics of amprenavir and ritonavir.
Interaktionsundersøgelser er kun udført hos voksne
Interaction studies have only been performed in adults.
4. 3)
• Associations contraindicated (see section 4.3)
CYP3A4- substrater med smalt terapeutisk vindue Telzir må ikke administreres samtidig med lægemidler med smalt terapeutisk vindue hvis aktive stoffer er substrater for cytokrom P450 3A4 (CYP3A4).
CYP3A4 substrates with narrow therapeutic index Telzir must not be administered concurrently with medicinal products with narrow therapeutic windows containing active substances that are substrates of cytochrome P450 3A4 (CYP3A4).
Hermed øges plasmaniveauet af de aktive stoffer, hvilket kan medføre alvorlige og/ eller livstruende bivirkninger såsom hjertearytmi (f. eks. amiodaron, astemizol, bepridil, cisaprid, pimozid, quinidin, terfanain), perifere vasospasmer eller iskæmi (f. eks. ergotamin, dihydroergotamin).
Co-administration may result in competitive inhibition of the metabolism of these active substances thus increasing their plasma level and leading to serious and / or life-threatening adverse reactions such as cardiac arrhythmia (e. g. amiodarone, astemizole, bepridil, cisapride, pimozide, quinidine, terfenadine) or peripheral vasospasm or ischaemia (e. g. ergotamine, dihydroergotamine).
CYP2D6- substrater med smalt terapeutisk vindue Kombinationsbehandlingen med Telzir og ritonavir må ikke administreres samtidig med lægemidler indeholdende aktive stoffer, der i høj grad afhænger af CYP2D6 metabolismen og for hvilke en for - øget plasmakoncentration kan medføre alvorlige og/ eller livstruende bivirkninger.
CYP2D6 substrates with narrow therapeutic index Telzir with ritonavir must not be co-administered with medicinal products containing active substances that are highly dependent on CYP2D6 metabolism and for which elevated plasma concentrations are associated with serious and / or life-threatening adverse reactions.
6 Rifampicin Rifampicin er en potent CYP3A4- inducer og har vist sig at forårsage en reduktion i amprenavir AUC med 82%, hvilket kan føre til manglende virologisk effekt og resistensudvikling.
Rifampicin Rifampicin is a strong CYP3A4 inducer and has been shown to cause an 82% decrease in amprenavir AUC, which can result in virological failure and resistance development.
4. 3).
The combination of rifampicin and Telzir with concomitant low-dose ritonavir is contraindicated (see section 4.3).
Prikbladet perikum (Hypericum perforatum) Serumniveauet for amprenavir kan reduceres ved samtidig anvendelse af naturprodukter indeholdende prikbladet perikum (Hypericum perforatum).
St John’ s wort (Hypericum perforatum) Serum levels of amprenavir and ritonavir can be reduced by concomitant use of the herbal preparation St John’ s wort (Hypericum perforatum).
Naturprodukter indeholdende prikbladet perikum bør derfor ikke kombineres med Telzir og ritonavir.
Herbal preparations containing St John’ s wort should therefore not be combined with Telzir with ritonavir.
Hvis en patient allerede tager prikbladet perikum, skal niveauet for amprenavir, ritonavir og om muligt også virusniveauet tjekkes, og behandlingen med prikbladet perikum skal afbrydes.
If a patient is already taking St John’ s wort, check amprenavir, ritonavir and if possible viral levels and stop St John’ s wort.
Niveauet af amprenavir og ritonavir kan stige ved afbrydelse af behandlingen med prikbladet perikum.
Amprenavir and ritonavir levels may increase on stopping St John’ s wort.
Den induktive effekt kan vedvare i op til 2 uger efter ophør af behandlingen med prikbladet perikum.
The inducing effect may persist for at least 2 weeks after cessation of treatment with St John’ s wort.
• Andre kombinationer
• Other combinations
Non- nukleosid revers transkriptasehæmmere
Non-nucleoside reverse transcriptase inhibitors
Der ses ingen klinisk relevant interaktion, når fosamprenavir 700 mg 2 gange daglig og ritonavir 100 mg 2 gange daglig anvendes samtidig med efavirens (600 mg 1 gang daglig).
Efavirenz: there was no clinically relevant interaction when fosamprenavir 700 mg twice daily and ritonavir 100 mg twice daily was used concurrently with efavirenz (600 mg once daily).
Ved samtidig brug af fosamprenavir 700 mg 2 gange daglig, ritonavir 100 mg 2 gange daglig og nevirapine 200 mg 2 gange daglig blev der ikke ingen klinisk relevante interaktioner påvist.
Nevirapine: there was no clinically relevant interaction when fosamprenavir 700 mg twice daily and ritonavir 100 mg twice daily was used concurrently with nevirapine (200 mg twice daily).
Nukleosid/ nucleotid revers transkriptasehæmmere
Nucleoside / Nucleotide reverse transcriptase inhibitors
Interaktionsstudier med abacavir, lamivudin og zidovudin er udført for amprenavir men uden samtidig administration af ritonavir.
Interaction studies with abacavir, lamivudine and zidovudine have been performed with amprenavir without ritonavir.
Baseret på data opnået i disse studier og fordi ritonavir ikke forventes at have nogen signifikant indvirkning på farmakokinetikken for NRTI’ erne, forventes den samtidige administration af fosamprenavir og ritonavir med disse lægemidler ikke at ændre virkningen af disse.
Based on data derived from these studies and because ritonavir is not expected to 7 have a significant impact on the pharmacokinetics of NRTIs, the co-administration of fosamprenavir and ritonavir with these medicinal products is not expected to significantly alter the exposure of the co-administered active substances.
Der er ikke udført farmakokinetiske studier med fosamprenavir i kombination med didanosin.
Didanosine chewable tablet: no pharmacokinetic study has been performed with fosamprenavir in combination with didanosine.
En klinisk signifikant interaktion, på grund af stigning i mavens pH som følge af didanosins antacidaindhold, er usandsynlig, og det vurderes unødvendigt med dosisseparation eller justering når fosamprenavir og didanosin administreres samtidig (se afsnittet om antacida).
Clinically significant interaction resulting from an increase in the stomach pH due to the didanosine antacid component is unlikely and no dose separation or adjustment is considered necessary when fosamprenavir and didanosine are administered concomitantly (see chapter, Antacids).
Der forventes ingen signifikant interaktion med didanosin enterokapsel.
No significant interaction is expected with didanosine gastro-resistant capsule.
Der kan ikke gives doseringsanbefalinger for samtidig administration af fosamprenavir og ritonavir med tenofovir.
Tenofovir: no recommendations can be drawn at this stage on the co-administration of fosamprenavir with ritonavir with tenofovir.
Proteasehæmmere
Protease Inhibitors
Lopinavir/ ritonavir:
Lopinavir / ritonavir:
Samtidig administration af lopinavir/ ritonavir og fosamprenavir ved standarddoser medfører et signifikant fald i koncentrationen af amprenavir.
Co-administration of standard doses of lopinavir/ ritonavir with fosamprenavir results in a significant reduction in amprenavir concentrations.
Samtidig administration af forhøjede doser fosamprenavir 1400 mg 2 gange daglig og lopinavir/ ritonavir 533/ 133 mg 2 gange daglig til tidligere PI- behandlede patienter medførte en højere incidens af gastrointestinale bivirkninger og en stigning i triglycerider i kombinationsregimet uden øgning af den virologiske effekt sammenlignet med standarddoser af fosamprenavir/ ritonavir.
Co-administration of increased doses of fosamprenavir 1400mg twice daily with lopinavir/ ritonavir 533/ 133mg twice daily to PI-experienced patients resulted in a higher incidence of gastrointestinal adverse events and elevations in triglycerides with the combination regimen without increases in virological efficacy, when compared with standard doses of fosamprenavir/ ritonavir.
Derfor frarådes samtidig brug af disse lægemidler.
Therefore, concomitant administration of these medicinal products is not recommended.
Der er ikke foretaget interaktionsstudier af fosamprenavir og ritonavir i kombination med protease - hæmmerne indinavir, saquinavir, nelfinavir og atazanavir.
No interaction studies have been undertaken between fosamprenavir with ritonavir and the protease inhibitors: indinavir, saquinavir, nelfinavir and atazanavir.
7 Antibiotika/ svampemidler
Antibiotics / Antifungals
Samtidig administration kan resultere i en moderat stigning i koncentrationen af clarithromycin hos disse patienter.
Clarithromycin: a reduction in the clarithromycin dose should be considered when co-administered with Telzir with ritonavir in patients with renal impairment as moderate increases in clarithromycin concentrations are expected when co-administered with Telzir with ritonavir.
Samtidig administration kan medføre en stigning i plasmakoncentrationen for erythromycin.
Erythromycin: no pharmacokinetic study has been performed with fosamprenavir with ritonavir in combination with erythromycin, however, plasma levels of erythromycin may be increased when co-administered.
Samtidig administration af fosamprenavir 700 mg med ritonavir 100 mg 2 gange daglig og ketoconazol 200 mg 1 gang daglig forøgede plasmaketonazol Cmax med 25% og forøgede AUC( 0- τ) til værdier 2, 69 gange større end dem observeret ved samtidig administration af ketoconazol 200 mg 1 gang daglig uden fosamprenavir og ritonavir.
Ketoconazole / Itraconazole: co-administration of fosamprenavir 700 mg with ritonavir 100 mg twice daily and ketoconazole 200 mg once daily increased plasma ketoconazole Cmax by 25% and increased AUC(0-τ) to values 2.69-fold those observed on administration of ketoconazole 200 mg once daily without concurrent fosamprenavir with ritonavir.
Høje doser (> 200 mg/ dag) af ketoconazol eller itraconazol bør ikke anvendes sammen med Telzir og ritonavir.
When used with Telzir with ritonavir, high doses (> 200 mg/ day) of ketoconazole or itraconazole are not recommended.
Sammenlignet med administration af rifabutin alene (300 mg 1 gang daglig) giver administration af nedsat dosis rifabutin (150 mg hver anden dag) samtidig med administration af fosamprenavir 700 mg 2 gange daglig og ritonavir 100 mg 2 gange daglig uændret plasma rifabutin AUC (0- 48) og nedsat Cmax med 14%.
Rifabutin: compared to rifabutin administered alone (300 mg once daily), plasma rifabutin AUC (0- 48) was unchanged and Cmax was decreased 14% following co-administration of reduced doses of rifabutin (150 mg every other day) with fosamprenavir 700 mg twice daily with ritonavir 100 mg twice daily.