FrancophonIA/ELRC3.0 huggingface dataset:
English: Pharmacokinetic studies have not been performed with Atripla in infants and children under 18 years of age (see section 4.2).
Danish: Der er ikke udført farmakokinetiske studier med Atripla hos spædbørn og børn under 18 år (se pkt.
English: Atripla can reduce the amount of itraconazole or posaconazole in your blood.
Danish: Atripla kan nedsætte mængden af itraconazol eller af posaconazol i blodet.
English: When used in combination with efavirenz and two NRTIs, 533/133 mg lopinavir/ritonavir (soft capsules) twice daily yielded similar lopinavir plasma concentrations as compared to lopinavir/ritonavir (soft capsules) 400/100 mg twice daily without efavirenz (historical data).
Danish: Når det blev anvendt i kombination med efavirenz og to NRTIer, gav lopinavir/ritonavir 533/133 mg (bløde kapsler) to gange dagligt de samme lopinavirplasma-koncentrationer sammenlignet med lopinavir/ritonavir (bløde kapsler) 400/100 mg to gange dagligt uden efavirenz (historiske data).
English: Therefore Atripla should not be used during breast-feeding.
Danish: Atripla bør derfor ikke anvendes under amning.
English: Co-administration of ritonavir at doses of 600 mg and Atripla is not recommended.
Danish: Samtidig administration af ritonavir i doser på 600 mg og Atripla frarådes.
English: Talk to your doctor or pharmacist before taking Atripla.
Danish: Kontakt lægen eller apotekspersonalet, før De tager Atripla.
English: In both studies, plasma progesterone levels for subjects receiving efavirenz and DMPA remained low consistent with suppression of ovulation.
Danish: I begge studier forblev progesteronplasmakoncentrationerne hos de patienter, der fik efavirenz og DMPA, lave i overensstemmelse med undertrykkelsen af ovulationen.
English: Uncommon suicide attempt3, suicide ideation3, psychosis3, mania3, paranoia3, hallucination3, euphoric mood3, affect lability3, confusional state3, aggression3, catatonia3
Danish: Suicidalforsøg3, suicidaltanker3, psykose3, mani3, paranoia3, hallucinationer3, eufori3, affektlabilitet3, forvirret tilstand3, agitation3, katatoni3
English: Exposures of raltegravir (a UGT1A1 substrate) are reduced in the presence of efavirenz (see section 4.5, Table 1).
Danish: Eksponeringen for raltegravir (et substrat for UGT1A1) er reduceret ved tilstedeværelse af efavirenz (se pkt.
English: Laboratory tests should be performed to evaluate their liver disease at periodic intervals (see section 4.2).
Danish: Der bør regelmæssigt udføres laboratorietests til evaluering af deres leversygdom (se pkt.
English: - Medicines used to treat infection with the hepatitis C virus: boceprevir, elbasvir/grazoprevir,
Danish: - Medicin til behandling af hepatitis C-virusinfektion: Boceprevir, elbasvir/grazoprevir,
English: However, malformations were observed in 3 of 20 foetuses/newborns from efavirenz-treated cynomolgus monkeys given doses resulting in plasma efavirenz concentrations similar to those seen in humans.
Danish: Der er imidlertid set misdannelser hos 3 ud af 20 fostre/nyfødte fra efavirenzbehandlede cynomolgusaber, der fik indgivet en dosis, der resulterede i efavirenzkoncentrationer i plasma lig dem, der er set hos mennesker.
English: Clinically significant interactions have not been found and would not be expected since the NRTIs are metabolised via a different route than efavirenz and would be unlikely to compete for the same metabolic enzymes and elimination pathways.
Danish: Klinisk signifikante interaktioner blev ikke fundet og forventes ikke, da NRTIer metaboliseres via en anden vej end efavirenz, og det ville være usandsynligt, at de ville konkurrere om de samme metaboliske enzymer og eliminationsveje.
English: High density polyethylene (HDPE) bottle with a polypropylene child-resistant closure containing 30 film-coated tablets and silica gel desiccant.
Danish: Beholder af højdensitetspolyethylen (HDPE) med børnesikret lukke af polypropylen indeholdende 30 filmovertrukne tabletter sammen med silicagel-tørremiddel.
English: In in vitro studies efavirenz did not inhibit CYP2E1 and inhibited CYP2D6 and CYP1A2 only at concentrations well above those achieved clinically.
Danish: I in vitro-studierne hæmmede efavirenz ikke CYP2E1og hæmmede kun CYP2D6 og CYP1A2 ved koncentrationer, der lå langt over de klinisk opnåede.
English: Children and adolescents - Do not give Atripla to children and adolescents under 18 years of age.
Danish: - Giv ikke Atripla til børn og unge under 18 år.
English: Voriconazole: Co-administration of standard doses of efavirenz and voriconazole is contraindicated.
Danish: Voriconazol: Samtidig administration af efavirenz og voriconazol standarddoser er kontraindiceret.
English: Limited data suggest there is no clinically significant effect on valproic acid pharmacokinetics.
Danish: Begrænsede data antyder, at der ikke er nogen klinisk signifikant virkning på farmakokinetikken af valproat.
English: Uncommon convulsions3, amnesia3, thinking abnormal3, ataxia3, coordination abnormal3, agitation3, tremor
Danish: Kramper3, amnesi3, abnorm tankevirksomhed3, ataksi3, unormal koordination3, agitation3, tremor
English: Neither emtricitabine nor tenofovir inhibited in vitro drug metabolism mediated by any of the major human CYP isoforms involved in drug biotransformation.
Danish: Hverken emtricitabin eller tenofovir hæmmede lægemiddelmetabolismen in vitro ved hjælp af nogle af de større humane CYPisoformer, der er involveret i lægemiddelbiotransformationen.
English: Co-administration of tenofovir disoproxil and didanosine at a dose of 400 mg daily has been associated with a significant decrease in CD4 cell count, possibly due to an intracellular interaction increasing phosphorylated (i.e. active) didanosine.
Danish: Samtidig administration af tenofovirdisoproxil og didanosin i en dosis på 400 mg dagligt er blevet associeret med et signifikant fald i CD4-celletal, hvilket muligvis skyldes en intracellulær interaktion, som øger phosphoryleret (dvs. aktivt) didanosin.
English: Patients co-infected with HIV and HBV who discontinue Atripla must be closely monitored with both clinical and laboratory follow-up for at least four months after stopping treatment with Atripla.
Danish: Patienter med hiv-infektion, som samtidigt er inficerede med HBV, og som seponerer behandlingen med Atripla, bør overvåges nøje med både klinisk og laboratoriemæssig opfølgning i mindst 4 måneder efter, at behandling med Atripla er ophørt.
English: Total active HMG Co-A reductase inhibitors:
Danish: Totalt antal aktive HMG Co-A reduktasehæmmere:
English: - The other ingredients in the tablet film coating are iron oxide black, iron oxide red, macrogol 3350, poly(vinyl alcohol), talc, titanium dioxide.
Danish: - Øvrige indholdsstoffer i tabletovertrækket: sort jernoxid, rød jernoxid, macrogol 3350, poly(vinylalkohol), talkum, titandioxid.
English: • increased cholesterol in the blood
Danish: • Forhøjet kolesterol i blodet
English: (competitive inhibition of oxidative metabolism)
Danish: (kompetitiv hæmning af oxidativ metabolisme)
English: Co-administration with drugs that are known to prolong the QTc interval (proarrhythmic).
Danish: Samtidig administration med lægemidler, som vides at forlænge QTc-intervallet (proarytmika).
English: 2 This adverse reaction may occur as a consequence of proximal renal tubulopathy.
Danish: 2 Denne bivirkning kan forekomme som resultat af proksimal renal tubulopati.
English: If you are taking any of these medicines, tell your doctor immediately.
Danish: Hvis De tager et eller flere af disse lægemidler, skal De straks fortælle det til Deres læge.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl altid lægen eller apotekspersonalet, hvis De tager anden medicin eller har gjort det for nylig.
English: The demonstration of the benefit of Atripla is primarily based on 48-week data from a clinical study in which patients with stable virologic suppression on a combination antiretroviral therapy changed to Atripla (see section 5.1).
Danish: Påvisning af Atriplas gavnlige virkning er primært baseret på 48-ugers data fra et klinisk studie, hvor patienter med stabil virologisk suppression i antiretroviral kombinationsbehandling skiftede til Atripla (se pkt.
English: • decreased sexual drive
Danish: • Nedsat sexlyst
English: Do not breast-feed during treatment with Atripla.
Danish: De må ikke amme under behandling med Atripla.
English: The degree of renal impairment was defined according to baseline creatinine clearance (normal renal function when creatinine clearance > 80 ml/min; mild impairment with creatinine clearance=50 to 79 ml/min; moderate impairment with creatinine clearance=30 to 49 ml/min and severe impairment with creatinine clearance=10 to 29 ml/min).
Danish: Graden af nedsat nyrefunktion blev defineret i henhold til baseline kreatininclearance (normal nyrefunktion ved kreatininclearance > 80 ml/min; let nedsat funktion ved kreatininclearance = 50-79 ml/min; moderat nedsat funktion ved kreatininclearance = 30-49 ml/min og svær nedsat funktion ved kreatininclearance = 10-29 ml/min).
English: False-positive urine cannabinoid test results have been reported with some screening assays in uninfected and HIV infected subjects receiving efavirenz.
Danish: Der er rapporteret falsk positive resultater for cannabinoid i urinprøver hos ikke-inficerede og hiv-inficerede personer, som fik efavirenz, med nogle screeningstests.
English: In a 144-week controlled clinical study that compared tenofovir disoproxil with stavudine in combination with lamivudine and efavirenz in antiretroviral-naïve patients, small decreases in bone mineral density of the hip and spine were observed in both treatment groups.
Danish: I et 144-ugers klinisk studie, som sammenlignede tenofovirdisoproxil med stavudin i kombination med lamivudin og efavirenz til antiretroviral-naive patienter, blev der observeret små fald i knoglemineraltætheden i hofte og rygsøjle i begge behandlingsgrupper.
English: Levonorgestrel (active metabolite):
Danish: Levonorgestrel (aktiv metabolit):
English: Side effects to the liver: If you are also infected with hepatitis B virus, you may experience a worsening of hepatitis after discontinuation of treatment (see section 3).
Danish: Bivirkninger, som påvirker leveren: Hvis De også har en hepatitis B-virusinfektion, kan De komme ud for en forværring af Deres hepatitis efter behandlingsophør (se punkt 3).
English: • Genotypic resistance to efavirenz, predominantly the K103N mutation, developed in virus from 13/19 (68%) patients in the efavirenz + emtricitabine + tenofovir disoproxil group and in virus from 21/29 (72%) patients in the efavirenz + lamivudine/zidovudine group.
Danish: • Genotypisk resistens over for efavirenz, overvejende K103N-mutationen, udviklede sig i virus fra 13/19 (68%) af patienterne i efavirenz + emtricitabin + tenofovirdisoproxil-gruppen og i virus fra 21/29 (72%) af patienterne i efavirenz + lamivudin/zidovudin-gruppen.
English: Resistance to emtricitabine or tenofovir has been seen in vitro and in some HIV-1 infected patients due to the development of an M184V or M184I substitution in RT with emtricitabine or a K65R substitution in RT with tenofovir.
Danish: Der er observeret resistens over for emtricitabin og tenofovir in vitro og hos nogle hiv-1-inficerede patienter på grund af udvikling af M184V- eller M184I-substitution i RT med emtricitabin eller K65Rsubstitution i RT med tenofovir.
English: The bioequivalence of one Atripla film-coated tablet with one efavirenz 600 mg film-coated tablet plus one emtricitabine 200 mg hard capsule plus one tenofovir disoproxil 245 mg film-coated tablet (equivalent to 300 mg tenofovir disoproxil fumarate) administered together, was established following single dose administration to fasting healthy subjects in study GS-US-177-0105 (see Table 6).
Danish: Bioækvalensen af en filmovertrukken Atripla-tablet sammen med en 600 mg filmovertrukken efavirenz-tablet plus en 200 mg hård kapsel emtricitabin plus en 245 mg filmovertrukken tenofovirdisoproxil-tablet (svarende til 300 mg tenofovirdisoproxilfumarat) administreret samtidigt blev etableret efter administration af en enkelt dosis til raske fastende deltagere i studie GS-US-177-0105 (se tabel 6).
English: Post-marketing reports of hepatic failure also occurred in patients with no pre-existing hepatic disease or other identifiable risk factors (see section 4.8).
Danish: Efter markedsføring er der også indberettet om leversvigt hos patienter uden præeksisterende leversygdom eller andre identificerede risikofaktorer (se pkt.
English: • inflammation of the kidney, passing a lot of urine and feeling thirsty
Danish: • Nyrebetændelse, udskillelse af store mængder urin og en fornemmelse af at være tørstig
English: Patients with pre-existing liver dysfunction including chronic active hepatitis have an increased frequency of liver function abnormalities during combination antiretroviral therapy (CART) and should be monitored according to standard practice.
Danish: Hos patienter med tidligere tilfælde af leverdysfunktion, herunder kronisk aktiv hepatitis, er der en øget forekomst af unormal leverfunktion under antiretroviral kombinationsbehandling (CART), og disse patienter bør monitoreres i henhold til standardprocedurer.
English: In HIV infected patients with severe immune deficiency at the time of institution of CART, an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Danish: Hos hiv-inficerede patienter med svær immuninsufficiens kan der ved initiering af CART opstå en inflammatorisk reaktion på asymptomatiske eller residuale opportunistiske patogener, som kan forårsage alvorlige kliniske tilstande eller forværring af symptomer.
English: • liver and pancreas problems
Danish: • Problemer med lever og bugspytkirtel
English: The pharmacokinetics of emtricitabine and tenofovir are similar in male and female patients.
Danish: Emtricitabins og tenofovirs farmakokinetik er ens hos mænd og kvinder.
English: Hepatobiliary disorders: Common elevated aspartate aminotransferase (AST), elevated alanine aminotransferase (ALT), elevated gammaglutamyltransferase (GGT)
Danish: Forhøjet aspartataminotransferase (ASAT), forhøjet alaninaminotransferase (ALAT), forhøjet gammaglutamyltransferase (GGT)
English: - Independent of a history of liver disease, your doctor will consider regular blood tests to check how your liver is working.
Danish: Uanset om De tidligere har haft en leversygdom, vil Deres læge overveje at tage regelmæssige blodprøver for at kontrollere, hvordan Deres lever fungerer.
English: elevated serum AST and/or elevated serum ALT, hyperbilirubinaemia increased transaminases
Danish: Forhøjet serum-ASAT og/eller forhøjet serum-ALAT, hyperbilirubinæmi
English: Carcinogenicity studies showed an increased incidence of hepatic and pulmonary tumours in female mice, but not in male mice.
Danish: Karcinogenicitetsstudier viste en øget forekomst af hepatiske og pulmonære tumorer hos hunmus, men ikke hos hanmus.
English: Based on the concentration-QTc relationship, the mean QTc prolongation and its upper bound 90% confidence interval are 8.7 ms and 11.3 ms in subjects with CYP2B6*6/*6 genotype following the administration of 600 mg daily dose for 14 days
Danish: På baggrund af forholdet mellem koncentration og QTc-interval er den gennemsnitlige forlængelse af QTc-intervallet og dets øvre grænse for 90 %-konfidensintervallet 8,7 ms og 11,3 ms hos forsøgspersoner med genotype CYP2B6 *6/*6 efter administration af en daglig dosis på 600 mg i 14 dage (se pkt.
English: Two subjects with confirmed virologic rebound developed NNRTI resistance-associated substitutions to efavirenz including K103N, V106V/I/M and Y188Y/C reverse transcriptase substitutions at week 240 (96 weeks on Atripla) and week 204 (60 weeks on Atripla).
Danish: To patienter med bekræftet virologisk rebound udviklede NNRTI-resistens-associerede substitutioner over for efavirenz, herunder K103N-, V106V/I/M- og Y188Y/C-revers transkriptase-substitutioner ved uge 240 (96 uger på Atripla) og ved uge 204 (60 uger på Atripla).
English: In patients with a history of renal dysfunction or in patients who are at risk of renal dysfunction, a more frequent monitoring of renal function is required.
Danish: Hos patienter med nedsat nyrefunktion i anamnesen eller patienter med risiko for nedsat nyrefunktion er hyppigere monitorering af nyrefunktionen nødvendig.
English: Limited data suggest that females may have higher exposure to efavirenz but they do not appear to be less tolerant of efavirenz.
Danish: Begrænsede data tyder på, at graden af påvirkning af efavirenz er højere for kvinder, men deres tolerabilitet af efavirenz synes ikke at være mindre.
English: Co-administration with elbasvir/grazoprevir due to the expected significant decreases in plasma concentrations of elbasvir and grazoprevir.
Danish: Samtidig administration med elbasvir/grazoprevir på grund af de forventede signifikante fald i plasmakoncentrationer af elbasvir og grazoprevir.
English: Patients with liver disease including chronic hepatitis B or C, who are treated with combination antiretrovirals, have a higher risk of severe and potentially life-threatening liver problems.
Danish: Patienter med leversygdom, herunder kronisk hepatitis B eller C, som er i behandling med antiretroviral kombinationsmedicin, har større risiko for alvorlige eller måske livstruende leverproblemer.
English: As a general rule, it is recommended that HIV infected women do not breast-feed their infants in order to avoid transmission of HIV to the infant.
Danish: For at undgå overførsel af hiv til spædbørn anbefales det generelt, at hiv-inficerede kvinder ikke ammer deres børn.
English: Other medicines and Atripla You must not take Atripla with certain medicines.
Danish: Brug af anden medicin sammen med Atripla De må ikke tage Atripla sammen med visse andre lægemidler.
English: In a drug interaction study, carbamazepine plasma concentrations were decreased when carbamazepine was co-administered with efavirenz (see section 4.5).
Danish: I et interaktionsstudie sås lavere carbamazepin plasmakoncentrationer, når carbamazepin blev administreret sammen med efavirenz (se pkt.
English: Nucleos(t)ide analogues may impact mitochondrial function to a variable degree, which is most pronounced with stavudine, didanosine and zidovudine.
Danish: Nukleosid-/nukleotid-analoger kan påvirke mitokondriefunktionen i varierende grad, dette er mest udtalt for stavudin, didanosin og zidovudin.
English: Atripla may interact with other medicines, including herbal preparations such as Ginkgo biloba extracts.
Danish: Atripla kan påvirke virkningen af anden medicin, herunder naturlægemidler med Ginkgo biloba-ekstrakt (tempeltræ-ekstrakt).
English: Tenofovir disoproxil is converted in vivo to tenofovir, a nucleoside monophosphate (nucleotide) analogue of adenosine monophosphate.
Danish: Tenofovirdisoproxil omdannes in vivo til tenofovir, der er en nukleosidmonophosphat (nukleotid) analog af adenosinmonophosphat.
English: Efavirenz, emtricitabine and tenofovir have been shown to be excreted in human milk.
Danish: Efavirenz, emtricitabin og tenofovir udskilles i human mælk.
English: Efavirenz: Non-clinical safety pharmacology studies on efavirenz reveal no special hazard for humans.
Danish: Efavirenz: Prækliniske studier af sikkerhedsfarmakologi for efavirenz viser ingen speciel risiko for mennesker.
English: Dihydroartemisinin (active metabolite):
Danish: Dihydroartemisinin (aktiv metabolit):
English: Severe rash associated with blistering, moist desquamation or ulceration has been reported in less than 1% of patients treated with efavirenz (see section 4.8).
Danish: Der er rapporteret svært udslæt, ledsaget af blæredannelse, fugtig afskalning eller ulceration hos mindre end 1% af de patienter, der er behandlet med efavirenz (se pkt.
English: - The other ingredients in the tablet are croscarmellose sodium, hyprolose, magnesium stearate, microcrystalline cellulose, sodium laurilsulfate.
Danish: - Øvrige indholdsstoffer i tabletten: croscarmellosenatrium, hydroxypropylcellulose, magnesiumstearat, mikrokrystallinsk cellulose, natriumlaurilsulphat.
English: Blood and lymphatic system disorders: Common neutropenia
Danish: Blod og lymfesystem: Almindelig
English: Tenofovir disoproxil should be avoided in patients with HIV-1 harbouring the K65R mutation.
Danish: Tenofovirdisoproxil bør undgås hos patienter med hiv-1 med stammer, som har K65R-mutationer.
English: Patients at risk of renal impairment (such as patients with baseline renal risk factors, advanced HIV disease, or patients receiving concomitant nephrotoxic medications) are at increased risk of experiencing incomplete recovery of renal function despite tenofovir disoproxil discontinuation (see section 4.4).
Danish: Patienter med risiko for nedsat nyrefunktion (såsom patienter med renale risikofaktorer ved baseline eller fremskreden hiv-sygdom eller patienter, der samtidig fik nefrotoksiske lægemidler) har en øget risiko for at opleve en ufuldstændig bedring af nyrefunktionen, trods seponering af tenofovirdisoproxil (se pkt.
English: Tenofovir pharmacokinetics were not substantially altered in subjects with hepatic impairment suggesting that no dose adjustment of tenofovir disoproxil is required in these subjects.
Danish: Tenofovirs farmakokinetik ændredes ikke væsentligt hos forsøgspersoner med nedsat leverfunktion, hvilket tyder på, at justering af tenofovirdisoporxildosis ikke var nødvendig hos disse forsøgspersoner.
English: It is recommended that creatinine clearance is calculated in all patients prior to initiating therapy with Atripla and renal function (creatinine clearance and serum phosphate) is also monitored after two to four weeks of treatment, after three months of treatment and every three to six months thereafter in patients without renal risk factors.
Danish: Desuden skal nyrefunktionen (kreatininclearance og serumphosphat) monitoreres efter to til fire ugers behandling, efter tre måneders behandling og derefter hver tredje til sjette måned hos patienter uden renale risikofaktorer.
English: • pain, stomach pain
Danish: • Smerter, mavesmerter
English: [outer packaging only]
Danish: [kun på ydre pakning]
English: Cmin: ↓ 12% (↓ 24 to ↑ 1)
Danish: Cmin: ↓ 12% (↓ 24 til ↑ 1)
English: In vitro and clinical pharmacokinetic interaction studies have shown the potential for CYP-mediated interactions involving emtricitabine and tenofovir disoproxil with other medicinal products is low.
Danish: In vitro-studier og kliniske farmakokinetiske interaktionsstudier har vist et lavt potentiale for CYPmedierede interaktioner, hvor emtricitabin og tenofovirdisoproxil er involveret sammen med andre lægemidler.
English: Nervous system symptoms associated with efavirenz usually begin during the first one or two days of therapy and generally resolve after the first two to four weeks.
Danish: Symptomer fra nervesystemet associeret med efavirenz starter sædvanligvis inden for de første 1-2 dage af behandlingen og svinder sædvanligvis efter de første 2-4 uger.
English: - Ginkgo biloba extracts (herbal preparation).
Danish: - Ginkgo biloba-ekstrakt (tempeltræ-ekstrakt, et naturlægemiddel).
English: Atripla may reduce the amount of atovaquone/proguanil or artemether/lumefantrine in your blood.
Danish: Atripla kan nedsætte mængden af atovaquon/proguanil eller artemether/lumefantrin i blodet.
English: Package leaflet: Information for the patient Atripla 600 mg/200 mg/245 mg film-coated tablets
Danish: Indlægsseddel: Information til patienten Atripla 600 mg/200 mg/245 mg filmovertrukne tabletter
English: This leaflet was last revised in .
Danish: Denne indlægsseddel blev senest ændret.
English: The following side effects may be signs of lactic acidosis: - deep rapid breathing - drowsiness - feeling sick (nausea), being sick (vomiting) and stomach pain.
Danish: Følgende bivirkninger kan være tegn på laktatacidose: Dyb, hurtig vejrtrækning Træthed Kvalme, opkastning og mavesmerter
English: Before starting treatment, your doctor may order blood tests to assess kidney function.
Danish: Før De starter på behandlingen, kan Deres læge bede om blodprøver til at vurdere Deres nyrefunktion.