natgillin/translations-raw huggingface dataset:
Der er ingen klinisk erfaring med Atripla til patienter, som har oplevet virologisk svigt i et first-line antiretroviralt regime eller i kombination med andre antiretrovirale lægemidler.
There is no clinical experience with Atripla in patients who are experiencing virological failure in a first-line antiretroviral treatment regimen or in combination with other antiretroviral agents.
Hos de fleste patienter forsvandt udslættet inden for 1 måned ved fortsat behandling med efavirenz.
In most patients rash resolved with continuing therapy with efavirenz within one month.
Disse patienter bør monitoreres omhyggeligt med henblik på efavirenz-bivirkninger, især symptomer fra nervesystemet.
These patients should be carefully monitored for efavirenz adverse reactions, especially nervous system symptoms.
Pakningsstørrelser og yderligere oplysninger Atripla indeholder:
Contents of the pack and other information What Atripla contains
Lægen kan også bede om blodprøver under behandlingen for at kontrollere Deres nyrer.
Your doctor may also order blood tests during treatment to monitor your kidneys.
Darunavir/ritonavir bør anvendes med forsigtighed sammen med Atripla.
Darunavir/ritonavir should be used with caution in combination with Atripla.
Yderligere oplysninger om Atripla findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Risikoen for krydsresistens mellem efavirenz og NRTIer er lille på grund af de forskellige bindingssteder og virkningsmekanisme.
The potential for cross-resistance between efavirenz and NRTIs is low because of the different binding sites on the target and mechanism of action.
Efter oral administration er emtricitabins eliminationshalveringstid ca. 10 timer.
Following oral administration, the elimination half-life of emtricitabine is approximately 10 hours.
Der sås en lignende reduktion i indinavireksponering, når indinavir 1.000 mg q8t blev givet sammen med efavirenz 600 mg q.d.
A similar reduction in indinavir exposures was observed when indinavir 1,000 mg q8h was given with efavirenz 600 mg q.d.
Deres læge vil måske tage blodprøver for at kontrollere, hvordan Deres lever fungerer, eller kan skifte Dem til anden medicin.
Your doctor may conduct blood tests in order to check how well your liver is working or may switch you to another medicine.
Leversvigt med efavirenz: Leversvigt, herunder tilfælde hos patienter uden præeksisterende leversygdom eller andre identificerede risikofaktorer, blev i indberetninger efter markedsføringen nogle gange karakteriseret ved et fulminant forløb, som i nogle tilfælde progredierede til transplantation eller død.
Hepatic failure with efavirenz: Hepatic failure, including cases in patients with no pre-existing hepatic disease or other identifiable risk factors, as reported post-marketing, were sometimes characterised by a fulminant course, progressing in some cases to transplantation or death.
Dosisjustering af det immunsupprimerende lægemiddel kan være nødvendig.
Dose adjustments of the immunosuppressant may be required.
30 filmovertrukne tabletter 90 (3 beholdere med 30) filmovertrukne tabletter.
30 film-coated tablets 90 (3 bottles of 30) film-coated tablets
Den kliniske signifikans af reducerede indinavirkoncentrationer er ikke fastslået, men omfanget af den observerede farmakokinetiske interaktion bør overvejes, når der vælges et regime, der indeholder både efavirenz, en Atriplakomponent samt indinavir.
While the clinical significance of decreased indinavir concentrations has not been established, the magnitude of the observed pharmacokinetic interaction should be taken into consideration when choosing a regimen containing both efavirenz, a component of Atripla, and indinavir.
Knogletoksicitet blev diagnosticeret som osteomalaci (aber) og nedsat knoglemineraltæthed (BMD) (rotter og hunde).
Bone toxicity was diagnosed as osteomalacia (monkeys) and reduced bone mineral density (BMD) (rats and dogs).
Atripla bør ikke anvendes til patienter, som har haft en livstruende hudreaktion (f.eks. StevensJohnsons syndrom) under NNRTI-behandling.
Atripla is not recommended for patients who have had a life-threatening cutaneous reaction (e.g., Stevens-Johnson syndrome) while taking an NNRTI.
Psykiatriske symptomer: Patienter med psykiske forstyrrelser i anamnesen synes at have større risiko for de alvorlige psykiske bivirkninger, som nævnt i efavirenzkolonnen i tabel 2.
Psychiatric symptoms: Patients with a history of psychiatric disorders appear to be at greater risk of serious psychiatric adverse reactions listed in the efavirenz column of Table 2.
Da efavirenz hovedsageligt metaboliseres ved hjælp af CYP-systemet, bør forsigtighed udvises ved administration af Atripla til patienter med let nedsat leverfunktion.
Since efavirenz is principally metabolised by the CYP system, caution should be exercised in administering Atripla to patients with mild hepatic impairment.
Når Atripla anvendes sammen med lav-dosis ritonavir, bør muligheden for øget forekomst af efavirenz-associerede bivirkninger overvejes pga. mulig farmakodynamisk interaktion.
When using Atripla with low-dose ritonavir, the possibility of an increase in the incidence of efavirenz-associated adverse events should be considered, due to possible pharmacodynamic interaction.
Efavirenz: Der har været 7 retrospektive rapporter om fund svarende til neuralrørsdefekter, herunder meningomyelocele, alle hos mødre, der i første trimester havde været eksponeret for efavirenzholdige regimer (eksklusive efavirenzholdige kombinationstabletter i faste doser).
Efavirenz: There have been seven retrospective reports of findings consistent with neural tube defects, including meningomyelocele, all in mothers exposed to efavirenz-containing regimens (excluding any efavirenz-containing fixed-dose combination tablets) in the first trimester.
Hos nogle patienter med fremskreden hiv-infektion (aids), som tidligere har haft følgesygdomme, kan tegn og symptomer på betændelse fra de tidligere infektioner forekomme kort efter, at anti-hiv-behandlingen er startet.
In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
En lignende tendens blev observeret i en undergruppeanalyse af behandlingserfarne patienter med hiv-1-rna < 75 kopier/ml ved baseline fra et retrospektivt kohorte-studie (data indsamlet i løbet af 20 måneder, se tabel 5).
A similar trend was observed in a sub-group analysis of treatment-experienced patients with baseline HIV-1 RNA < 75 copies/ml from a retrospective cohort study (data collected over 20 months, see Table 5).
48-ugers data viste, at høje niveauer af virologisk suppression, som var sammenlignelige med det oprindelige behandlingsregime, blev opretholdt hos patienter, som blev randomiseret til at skifte til Atripla (se tabel 4).
Forty-eight week data showed that high levels of virologic suppression, comparable to the original treatment regimen, were maintained in patients who were randomised to change to Atripla (see Table 4).
De hyppigst indberettede bivirkninger, som blev anset for at have en mulig eller sandsynlig forbindelse til Atripla, hos patienter, der blev behandlet i op til 48 uger i studie AI266073, var psykiske forstyrrelser (16%), lidelser i nervesystemet (13%) og gastrointestinale forstyrrelser (7%).
The most frequently reported adverse reactions considered possibly or probably related to Atripla among patients treated up to 48 weeks in study AI266073 were psychiatric disorders (16%), nervous system disorders (13%), and gastrointestinal disorders (7%).
Andre mulige alvorlige bivirkninger
Other possible serious side effects
Selvom in vitro-data tyder på, at efavirenz hæmmer CYP2C9 og CYP2C19, har der været modsigende rapporter om både forhøjede og reducerede eksponeringer for substrater for disse enzymer in vivo, når de administreres samtidigt med efavirenz.
Although in vitro data suggest that efavirenz inhibits CYP2C9 and CYP2C19, there have been contradictory reports of both increased and decreased exposures to substrates of these enzymes when co-administered with efavirenz in vivo.
Administration af efavirenzkapsler sammen med et måltid med stort fedtindhold forhøjede gennemsnitligt AUC og Cmax af efavirenz med henholdsvis 28% og 79% sammenlignet med administration under faste.
Administration of efavirenz capsules with a high fat meal increased the mean AUC and Cmax of efavirenz by 28% and 79%, respectively, compared to administration in a fasted state.
Stoffer, som er substrater for disse enzymer, kan have reducerede plasmakoncentrationer, når de administreres sammen med efavirenz.
Compounds that are substrates of these enzymes may have decreased plasma concentrations when co-administered with efavirenz.
Tabel 4: 48-ugers virkningdata fra studie AI266073, hvor Atripla blev administreret til virologisk supprimerede patienter i antiretroviral kombinationsbehandling.
Table 4: 48-week efficacy data from study AI266073 in which Atripla was administered to virologically suppressed patients on combination antiretroviral therapy
Kombinationen af efavirenz, emtricitabin og tenofovirdisoproxil er blevet undersøgt hos 460 patienter, enten som fast-dosis kombinationstabletten Atripla (studie AI266073) eller som præparater indeholdende de aktive stoffer (studie GS-01-934).
The combination of efavirenz, emtricitabine and tenofovir disoproxil has been studied in 460 patients either as the fixed-dose combination tablet Atripla (study AI266073) or as the component products (study GS-01-934).
Der forventes ingen klinisk signifikant interaktion, da simeprevir og emtricitabin elimineres via forskellige eliminationsveje.
Clinically significant interactions are not expected as simeprevir and emtricitabine are eliminated via different pathways.
Efavirenzkoncentrationer er ikke målt, der forventes ingen virkning.
Efavirenz concentrations not measured, no effect is expected.
Fund ved studier med rotter og aber viste, at der var en stofrelateret reduktion i den intestinale absorption af phosphat med potentiel, sekundær reduktion af BMD.
Findings in the rat and monkey studies indicated that there was a substance-related decrease in intestinal absorption of phosphate with potential secondary reduction in BMD.
Efter intravenøs administration var tenofovirs fordelingsvolumen ca. 800 ml/kg.
Following intravenous administration the volume of distribution of tenofovir was approximately 800 ml/kg.
(hæmning af CYP-medieret oxidativ metabolisme)
(inhibition of CYP-mediated oxidative metabolism)
Patienter med hiv-1 med stammer som har mutationer
Patients with HIV-1 harbouring mutations
Samtidig administration med voriconazol.
Co-administration with voriconazole.
Emtricitabin (n=45)
Emtricitabine (n=45)
Se produktresuméet for disse lægemidler.
Please refer to the Summary of Product Characteristics for these medicinal products.
Anencefali og unilateral anophthalmia med sekundær forstørrelse af tungen sås hos ét foster, microphthalmia hos et andet foster og ganespalte hos et tredje foster.
Anencephaly and unilateral anophthalmia with secondary enlargement of the tongue were observed in one foetus, microophthalmia was observed in another foetus and cleft palate was observed in a third foetus.
Emtricitabinresistente vira med M184V/I-mutationen var krydsresistente over for lamivudin, men beholdt følsomhed over for didanosin, stavudin, tenofovir og zidovudin.
Emtricitabine-resistant viruses with the M184V/I mutation were cross-resistant to lamivudine, but retained sensitivity to didanosine, stavudine, tenofovir and zidovudine.
- Medicin til behandling af svampeinfektioner (svampemiddel): Itraconazol eller posaconazol.
- Medicines used to treat fungal infections (antifungals): Itraconazole or posaconazole.
Disse patienter skal monitoreres omhyggeligt for bivirkninger og stigning i viræmi, da sikkerhedsprofilen for efavirenz er forskellig fra proteasehæmmeres sikkerhedsprofil.
These patients should be carefully monitored for rises in viral load and, since the safety profile of efavirenz differs from that of protease inhibitors, for adverse reactions.
Relevante antihistaminer og/eller kortikosteroider kan forbedre tolerabiliteten og fremskynde udslættets forsvinden.
Appropriate antihistamines and/or corticosteroids may improve tolerability and hasten the resolution of rash.
Der foreligger ingen data om sikkerheden og virkningen af Atripla i kombination med andre antiretrovirale lægemidler.
No data are available on the safety and efficacy of Atripla in combination with other antiretroviral agents.
• Søvnbesvær, unormale drømme, koncentrationsbesvær, døsighed
• difficulty sleeping, abnormal dreams, difficulty concentrating, drowsiness
Frekvenskategorien blev estimeret ud fra en statistisk beregning baseret på det totale antal patienter behandlet med efavirenz i kliniske studier (n=3.969) eller eksponeret for emtricitabin i randomiserede, kontrollerede kliniske studier - (n=1.563) eller eksponeret for tenofovirdisoproxil i randomiserede, kontrollerede, kliniske studier og i programmet for forlænget adgang (n=7.319).
The frequency category was estimated from a statistical calculation based on the total number of patients treated with efavirenz in clinical trials (n = 3,969) or exposed to emtricitabine in randomised controlled clinical trials (n = 1,563) or exposed to tenofovir disoproxil in randomised controlled clinical trials and the expanded access programme (n = 7,319).
- Sertralin, medicin til behandling af depression, fordi Deres læge kan finde det nødvendigt at ændre Deres sertralindosis.
- Sertraline, a medicine used to treat depression, as your doctor may need to change your dose of sertraline.
Tabel 5: Opretholdelse af rent virologisk respons (Kaplan Meier % (standardfejl) [95%CI]) i uge 48 hos behandlingserfarne patienter med hiv-1-rna < 75 kopier/ml ved baseline, som skiftede behandling til Atripla ifølge typen af tidligere antiretroviral behandling (Kaiser Permanente patient database) Tidligere Atriplakomponenter (N=299)
Table 5: Maintenance of pure virologic response (Kaplan Meier % (Standard Error) [95%CI]) at week 48 for treatment-experienced patients with baseline HIV-1 RNA < 75 copies/ml who had therapy switched to Atripla according to the type of prior antiretroviral regimen (Kaiser Permanente patient database)
1 Andre efavirenz resistensmutationer omfattede A98G (n=1), K103E (n=1), V179D (n=1), og M230L (n=1).
1 Other efavirenz resistance mutations included A98G (n=1), K103E (n=1), V179D (n=1), and M230L (n=1).
Samtidig administration af efavirenz og atorvastatin, pravastatin eller simvastatin påvirkede ikke efavirenz' AUC eller Cmax værdier.
Co-administration of efavirenz with atorvastatin, pravastatin, or simvastatin did not affect efavirenz AUC or Cmax values.
Emtricitabin viste antiviral aktivitet mod hiv-1 grupperne A, B, C, D, E, F og G. Tenofovir viste antiviral aktivitet mod hiv-1 grupperne A, B, C, D, E, F, G og O. Både emtricitabin og tenofovir viste stammespecifik aktivitet mod hiv-2 og antiviral aktivitet mod HBV.
Emtricitabine displayed antiviral activity against HIV-1 clades A, B, C, D, E, F, and G. Tenofovir displayed antiviral activity against HIV-1 clades A, B, C, D, E, F, G, and O. Both emtricitabine and tenofovir showed strain specific activity against HIV-2 and antiviral activity against HBV.
Atripla kan nedsætte mængden af statiner i blodet.
Atripla can reduce the amount of statins in your blood.
Psykiske bivirkninger ud over de ovenfor nævnte omfatter vrangforestillinger og neuroser.
Psychiatric side effects in addition to those listed above include delusions (false beliefs), neurosis.
- Hormonal prævention, såsom p-piller, injiceret prævention (for eksempel Depo-Provera) eller præventivt implantat (for eksempel Implanon): De skal også anvende pålidelig barriereprævention (se Graviditet og amning).
- Hormonal contraceptive, such as birth control pills, an injected contraceptive (for example, Depo-Provera), or a contraceptive implant (for example, Implanon): You must also use a reliable barrier method of contraception (see Pregnancy and breast-feeding).
Efavirenz reducerer plasmakoncentrationen af voriconazol signifikant, mens voriconazol også reducerer plasmakoncentrationen af efavirenz signifikant.
Efavirenz significantly decreases voriconazole plasma concentrations while voriconazole also significantly increases efavirenz plasma concentrations.
Emtricitabin og tenofovir, individuelt og i kombinationsbehandling, har udvist aktivitet mod HBV i farmakodynamiske studier (se pkt.
Emtricitabine and tenofovir individually and in combination have shown activity against HBV in pharmacodynamic studies (see section 5.1).
Et studie af efavirenz med multiple doser viste ingen signifikant påvirkning af efavirenz' farmakokinetik hos patienter med let nedsat leverfunktion (Child-Pugh-Turcotte klasse A) sammenlignet med kontrolgruppen.
A multiple-dose study of efavirenz showed no significant effect on efavirenz pharmacokinetics in patients with mild hepatic impairment (Child-Pugh-Turcotte Class A) compared with controls.
Efter oral administration var tenofovirs eliminationshalveringstid ca. 12-18 timer.
Following oral administration, the elimination half-life of tenofovir is approximately 12 to 18 hours.
Når efavirenz blev givet sammen med ritonavir 500 mg eller 600 mg to gange dagligt, tåltes kombinationen ikke godt (f.eks. forekom svimmelhed, kvalme, paræstesi og forhøjede leverenzymer).
When efavirenz was given with ritonavir 500 mg or 600 mg twice daily, the combination was not well tolerated (for example, dizziness, nausea, paraesthesia and elevated liver enzymes occurred).
Der kan ikke gives doseringsanbefaling for anvendelsen af Atripla sammen med carbamazepin.
No dose recommendation can be made for the use of Atripla with carbamazepine.
Ældre: Atripla er ikke blevet undersøgt hos patienter over 65 år.
Elderly: Atripla has not been studied in patients over the age of 65.
- Medicin til behandling af malaria: Atovaquon/proguanil eller artemether/lumefantrin.
- Medicines used to treat malaria: Atovaquone/proguanil or artemether/lumefantrine.
Kombination af emtricitabin og tenofovirdisoproxil: I studier af en måneds varighed eller derunder af genotoksicitet og af toksicitet efter gentagne doser med en kombination af disse to indholdsstoffer blev der ikke fundet nogen forværring af toksikologiske virkninger, sammenlignet med studier med de separate indholdsstoffer.
Combination of emtricitabine and tenofovir disoproxil: Genotoxicity and repeated-dose toxicity studies of one month or less with the combination of these two components found no exacerbation of toxicological effects compared to studies with the separate components.
Atazanavir/ritonavir: Der er ikke tilstrækkelig dokumentation til en doseringsanbefaling for atazanavir/ritonavir i kombination med Atripla.
Atazanavir/ritonavir: Insufficient data are available to make a dosing recommendation for atazanavir/ritonavir in combination with Atripla.
Lægen kan overveje at give Dem de aktive stoffer i Atripla hver for sig, hvis De har problemer eller det er nødvendigt at justere Deres dosis.
Your doctor may consider giving you the components of Atripla separately if you are having problems or need your dose adjusted.
Der er rapporteret om yderligere to tilfælde (1 prospektivt og 1 retrospektivt), herunder hændelser svarende til neuralrørsdefekter, med fastdosis-kombinationstabletten indeholdende efavirenz, emtricitabin og tenofovirdisoproxil.
Two additional cases (1 prospective and 1 retrospective) including events consistent with neural tube defects have been reported with the fixed-dose combination tablet containing efavirenz, emtricitabine, and tenofovir disoproxil.
Renalt eliminerede lægemidler: Da emtricitabin og tenofovir primært elimineres via nyrerne, kan samtidig administration af Atripla og lægemidler, der reducerer nyrefunktionen eller konkurrerer om aktiv tubulær udskillelse (f.eks. cidofovir) øge serumkoncentrationen af emtricitabin, tenofovir og/eller de samtidigt administrerede lægemidler.
Renally eliminated medicinal products: Since emtricitabine and tenofovir are primarily eliminated by the kidneys, co-administration of Atripla with medicinal products that reduce renal function or compete for active tubular secretion (e.g. cidofovir) may increase serum concentrations of emtricitabine, tenofovir and/or the co-administered medicinal products.
Hvis De holder op med at tage Atripla, skal De kontakte Deres læge, før De begynder at tage Atripla-tabletter igen.
If Atripla is stopped, speak to your doctor before you restart taking Atripla tablets.
For yderligere information se produktresuméerne for de individuelle komponenter med henblik på in vivo-resistens i forbindelse med disse lægemidler.
Please refer to the Summary of Product Characteristics for the individual components for additional information regarding in vivo resistance with these medicinal products.
Emtricitabintriphosphat og tenofovirdiphosphat hæmmer kompetitivt hiv-1 revers transkriptase, hvilket resulterer i dna-kædeblokering.
Emtricitabine triphosphate and tenofovir diphosphate competitively inhibit HIV-1 reverse transcriptase, resulting in DNA chain termination.
Efter oral administration fordeles emtricitabin bredt i hele kroppen.
After oral administration, emtricitabine is widely distributed throughout the body.
Patienter med let leversygdom (Child-Pugh-Turcotte (CPT), klasse A) kan behandles med den dosis, der normalt anbefales for Atripla (se pkt.
Patients with mild liver disease (Child-Pugh-Turcotte (CPT), Class A) may be treated with the normal recommended dose of Atripla (see sections 4.3, 4.4 and 5.2).
Nedbrydning af muskelvæv, kalktab fra knoglerne (med knoglesmerter, som nogle gange resulterer i knoglebrud), muskelsmerter, muskelsvaghed og nedsat kalium- eller phosphatniveau i blodet kan forekomme på grund af skader på celler i nyrerne (de tubulære celler).
The breakdown of muscle, softening of the bones (with bone pain and sometimes resulting in fractures), muscle pain, muscle weakness and decreases in potassium or phosphate in the blood may occur due to damage to kidney tubule cells.
Begrænset klinisk erfaring tyder på, at emtricitabin og tenofovirdisoproxil har anti-HBV-aktivitet, når de anvendes i antiretroviral kombinationsbehandling til at kontrollere hiv-infektion.
Limited clinical experience suggests that emtricitabine and tenofovir disoproxil have an anti-HBV activity when used in antiretroviral combination therapy to control HIV infection.
Svært nedsat leverfunktion (CPT klasse C) (se pkt.
Severe hepatic impairment (CPT, Class C) (see section 5.2).
Der forventes ingen klinisk signifikant interaktion, da vigabatrin og gabapentin udelukkende elimineres uændret i urinen, og det er usandsynligt, at de vil konkurrere om de samme metaboliske enzymer og eliminationsveje som efavirenz.
Clinically significant interactions are not expected since vigabatrin and gabapentin are exclusively eliminated unchanged in the urine and are unlikely to compete for the same metabolic enzymes and elimination pathways as efavirenz.
Hos nogle patienter med fremskreden leversygdom eller cirrose bør behandlingen ikke ophøre, fordi det kan medføre en forværring af Deres hepatitis, hvilket kan være livstruende.
In some patients with advanced liver disease or cirrhosis, stopping treatment is not recommended as this may lead to worsening of your hepatitis, which may be life-threatening.
Atripla skal seponeres hos patienter, der udvikler svært udslæt ledsaget af blæredannelse, afskalning, mucosapåvirkning eller feber.
Atripla must be discontinued in patients developing severe rash associated with blistering, desquamation, mucosal involvement or fever.