natgillin/translations-raw huggingface dataset:
3 Atripla må ikke gives samtidigt med terfenadin, astemizol, cisaprid, midazolam, triazolam, primozid, bepridil eller ergotalkaloider (f. eks. ergotamin, dihydroergotamin, ergonovin og methylergonovin), da konkurrence om cytochrom P450 (CYP) 3A4 fra efavirenz kan resultere i hæmning af metaboliseringen.
Atripla must not be administered concurrently with terfenadine, astemizole, cisapride, midazolam, triazolam, pimozide, bepridil, or ergot alkaloids (for example, ergotamine, dihydroergotamine,
4. 5).
3 ergonovine, and methylergonovine), because competition for cytochrome P450 (CYP) 3A4 by efavirenz could result in inhibition of metabolism and create the potential for serious and/ or life-threatening undesirable effects (for example, cardiac arrhythmias, prolonged sedation or respiratory depression) (see section 4.5).
4. 5).
John’ s wort (Hypericum perforatum) must not be used while taking Atripla due to the risk of decreased plasma concentrations and reduced clinical effects of efavirenz (see section 4.5).
4. 5).
Since Atripla is a fixed-dose combination product, the dose of efavirenz cannot be altered; therefore, voriconazole and Atripla must not be co-administered (see section 4.5).
Som en fast kombination bør Atripla ikke gives samtidigt med andre lægemidler, der indeholder nogle af de samme aktive komponenter, efavirenz, emtricitabin eller tenofovirdisoproxil - fumarat.
General: as a fixed combination, Atripla should not be administered concomitantly with other medicinal products containing any of the same active components, efavirenz, emtricitabine or tenofovir disoproxil fumarate.
4. 5).
Due to similarities with emtricitabine, Atripla should not be administered concomitantly with other cytidine analogues, such as lamivudine (see section 4.5).
Atripla må ikke gives samtidigt med adefovirdipivoxil.
Atripla should not be administered concomitantly with adefovir dipivoxil.
5. 1).
Currently available data indicate a trend that in patients on a PI-based antiretroviral regimen the switch to Atripla may lead to a reduction of the response to the therapy (see section 5.1).
Laktatacidose, som i regelen er forbundet med steatosis hepatis, er blevet indberettet i forbindelse med brugen af nukleosidanaloger.
Lactic acidosis: lactic acidosis, usually associated with hepatic steatosis, has been reported with the use of nucleoside analogues.
Tidligt optrædende symptomer (symptomatisk hyperlaktatæmi) er godartede fordøjelsessymptomer (kvalme, opkastning og mavesmerter), uspecifik utilpashed, appetitløshed, vægttab, symptomer i åndedrætsorganer (hurtig og/ eller dyb vejrtrækning) eller neurologiske symptomer (herunder motorisk svaghed).
Early symptoms (symptomatic hyperlactataemia) include benign digestive symptoms (nausea, vomiting and abdominal pain), non-specific malaise, loss of appetite, weight loss, respiratory symptoms (rapid and/ or deep breathing) or neurological symptoms (including motor weakness).
Laktatacidose har høj mortalitet og kan være forbundet med pancreatitis, leversvigt eller nyresvigt.
Lactic acidosis has a high mortality and may be associated with pancreatitis, liver failure or renal failure.
Laktatacidose indtrådte i regelen efter få eller adskillige måneders behandling.
Lactic acidosis generally occurred after a few or several months of treatment.
Behandling med nukleosidanaloger bør seponeres i tilfælde af symptomatisk hyperlaktatæmi og metabolisk acidose/ laktatacidose, progressiv hepatomegali eller hurtigt stigende aminotransferaseniveauer.
Treatment with nucleoside analogues must be discontinued in the setting of symptomatic hyperlactataemia and metabolic/ lactic acidosis, progressive hepatomegaly, or rapidly elevating aminotransferase levels.
Der bør udvises forsigtighed ved indgivelse af nukleosidanaloger til en patient (især overvægtige kvinder) med hepatomegali, hepatitis eller andre kendte risikofaktorer for leversygdom og steatosis hepatis (herunder visse lægemidler og alkohol).
Caution should be exercised when administering nucleoside analogues to any patient (particularly obese women) with hepatomegaly, hepatitis or other known risk factors for liver disease and hepatic steatosis (including certain medicinal products and alcohol).
Samtidig infektion med hepatitis C og behandling med alfa- interferon og ribavirin kan udgøre en særlig risiko.
Co-infection with hepatitis C and treatment with alpha interferon and ribavirin may constitute a special risk.
Patienter med øget risiko skal følges nøje.
Patients at increased risk must be followed closely.
Patienter, der får Atripla eller anden antiretroviral behandling, kan fortsat udvikle opportunistiske infektioner og andre HIV- relaterede komplikationer og bør derfor fortsætte under tæt klinisk observation af læger, der har erfaring med behandling af patienter med HIV- associerede sygdomme.
Opportunistic infections: patients receiving Atripla or any other antiretroviral therapy may continue to develop opportunistic infections and other complications of HIV infection, and therefore should remain under close clinical observation by physicians experienced in the treatment of patients with HIV associated diseases.
Patienter skal underrettes om, at det ikke er påvist, at antiretrovirale behandlinger, inklusive Atripla, forebygger risikoen for overførsel af HIV til andre ved seksuel kontakt eller kontaminering med blod.
Transmission of HIV: patients must be advised that antiretroviral therapies, including Atripla, have not been proven to prevent the risk of transmission of HIV to others through sexual contact or contamination with blood.
Hensigtsmæssige forsigtighedsregler skal derfor fortsat anvendes.
Appropriate precautions must continue to be used.
Atriplas farmakokinetik, sikkerhed og virkning er ikke fastslået hos patienter med signifikante, tilgrundliggende leversygdomme (se pkt.
Liver disease: the pharmacokinetics, safety and efficacy of Atripla have not been established in patients with significant underlying liver disorders (see section 5.2).
Atripla er kontraindiceret hos patienter med svær leverinsufficiens (se pkt.
Atripla is contraindicated in patients with severe hepatic impairment (see section 4.3).
Da efavirenz hovedsageligt metaboliseres ved hjælp af cytochrom P450 (CYP450) systemet, bør forsigtighed udvises ved administration af Atripla til patienter med mild til moderat leversygdom.
4 by the cytochrome P450 (CYP450) system, caution should be exercised in administering Atripla to patients with mild-to-moderate liver disease.
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.
4. 2).
Laboratory tests should be performed to evaluate their liver disease at periodic intervals (see section 4.2).
Hos patienter med tidligere tilfælde af leverdysfunktion, herunder kronisk aktiv hepatitis, er der en øget forekomst af unormal leverfunktion under antiretroviral kombinationsbehandling, og disse patienter bør monitoreres i henhold til standardprocedurer.
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 monitored according to standard practice.
Ved tegn på forværring af leversygdom eller vedvarende forhøjelse af serumtransaminaser til mere end 5 gange den øvre normalgrænse, skal fordelen ved fortsat behandling med Atripla vurderes i forhold til de potentielle risici ved signifikant levertoksicitet.
If there is evidence of worsening liver disease or persistent elevations of serum transaminases to greater than 5 times the upper limit of the normal range, the benefit of continued therapy with Atripla needs to be weighed against the potential risks of significant liver toxicity.
4. 8).
In such patients, interruption or discontinuation of treatment must be considered (see section 4.8).
Hos patienter med kronisk hepatitis B eller C, som er i antiretroviral behandling, er der en øget risiko for svære og potentielt fatale, hepatiske bivirkninger.
Patients with HIV and hepatitis B (HBV) or C virus (HCV) co-infection: patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reactions.
Læger bør holde sig til de aktuelle HIV- behandlingsretningslinjer for optimal håndtering af HIV- infektion hos patienter med samtidig infektion med HBV.
Physicians should refer to current HIV treatment guidelines for the optimal management of HIV infection in patients co-infected with HBV.
Sikkerhed og virkning af Atripla er ikke undersøgt til behandling af kronisk HBV- infektion.
The safety and efficacy of Atripla have not been studied for the treatment of chronic HBV infection.
Emtricitabin og tenofovir, individuelt og i kombinationsbehandling, har udvist aktivitet mod HBV i farmakodynamiske undersøgelser (se pkt.
Emtricitabine and tenofovir individually and in combination have shown activity against HBV in pharmacodynamic studies (see section 5.1).
Begrænset klinisk erfaring tyder på, at emtricitabin og tenofovirdisoproxilfumarat har anti- HBV- aktivitet, når de anvendes i antiretroviral kombinationsbehandling til at kontrollere HIV- infektion.
Limited clinical experience suggests that emtricitabine and tenofovir disoproxil fumarate have an anti-HBV activity when used in antiretroviral combination therapy to control HIV infection.
Seponering af behandlingen med Atripla hos patienter, der har både HIV og HBV, kan være forbundet med svær, akut forværring af hepatitis.
Discontinuation of Atripla therapy in patients co-infected with HIV and HBV may be associated with severe acute exacerbations of hepatitis.
Patienter med HIV- infektion, som samtidigt er inficerede med HBV, og som afbryder behandlingen med Atripla, bør overvåges nøje med både klinisk og laboratoriemæssig opfølgning i mindst 4 måneder efter, at behandling med Atripla er ophørt.
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.
Genoptagelse af hepatitis B- behandling kan være nødvendig.
If appropriate, resumption of anti-hepatitis B therapy may be warranted.
Psykiatriske bivirkninger er indberettet hos patienter behandlet med efavirenz.
Psychiatric symptoms: psychiatric adverse reactions have been reported in patients treated with efavirenz.
Efter markedsføring har der ligeledes været indberetninger vedrørende svær depression, selvmord, vrangforestillinger og psykose- lignende adfærd.
There have also been post-marketing reports of severe depression, death by suicide, delusions and psychosis-like behaviour.
4. 8).
Patients should be advised that if they experience symptoms such as severe depression, psychosis or suicidal ideation, they should contact their doctor immediately to assess the possibility that the symptoms may be related to the use of efavirenz, and if so, to determine whether the risk of continued therapy outweighs the benefits (see section 4.8).
Symptomer, der inkluderer, men ikke er begrænset til, svimmelhed, søvnløshed, søvnighed, nedsat koncentrationsevne og abnorme drømme er hyppigt indberettede bivirkninger hos patienter i kliniske undersøgelser i behandling med efavirenz 600 mg dagligt.
Nervous system symptoms: symptoms including, but not limited to, dizziness, insomnia, somnolence, impaired concentration and abnormal dreaming are frequently reported undesirable effects in patients receiving efavirenz 600 mg daily in clinical studies.
Svimmelhed er også set i kliniske undersøgelser med emtricitabin og tenofovirdisoproxilfumarat.
Dizziness was also seen in clinical studies with emtricitabine and tenofovir disoproxil fumarate.
4. 8).
Headache has been reported in clinical studies with emtricitabine (see section 4.8).
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.
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.
Der er set krampeanfald hos patienter i efavirenzbehandling, sædvanligvis i forbindelse med kramper i anamnesen.
5 Seizures: convulsions have been observed in patients receiving efavirenz, generally in the presence of a known medical history of seizures.
Patienter, som får krampestillende medicin, der primært metaboliseres i leveren, som f. eks. phenytoin, carbamazepin og phenobarbital, kan have brug for periodisk monitorering af plasmakoncentrationerne.
Patients who are receiving concomitant anticonvulsant medicinal products primarily metabolised by the liver, such as phenytoin, carbamazepine and phenobarbital, may require periodic monitoring of plasma levels.
4. 5).
In a drug interaction study, carbamazepine plasma concentrations were decreased when carbamazepine was co-administered with efavirenz (see section 4.5).
Atripla bør ikke anvendes til patienter med moderat eller svær nyreinsufficiens.
Atripla is not recommended for patients with moderate or severe renal impairment.
4. 2 og 5. 2).
Patients with moderate or severe renal impairment require a dose adjustment of emtricitabine and tenofovir disoproxil fumarate that cannot be achieved with the combination tablet (see sections 4.2 and 5.2).
4. 5).
If concomitant use of Atripla and nephrotoxic agents (e. g. aminoglycosides, amphotericin B, foscarnet, ganciclovir, pentamidine, vancomycin, cidofovir, interleukin-2) is unavoidable, renal function must be monitored weekly (see section 4.5).
4. 8).
Renal failure, renal impairment, elevated creatinine, hypophosphataemia and proximal tubulopathy (including Fanconi syndrome) have been reported with the use of tenofovir disoproxil fumarate in clinical practice (see section 4.8).
Desuden skal nyrefunktionen (kreatininclearance og serumphosphat) også monitoreres hver fjerde uge i løbet af det første år og derefter hver tredje måned.
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 every four weeks during the first year and then every three months.
Hos patienter med nedsat nyrefunktion i anamnesen eller patienter med risiko for nedsat nyrefunktion bør det overvejes at gennemføre hyppigere monitorering af nyrefunktionen.
In patients with a history of renal dysfunction or in patients who are at risk for renal dysfunction, consideration must be given to more frequent monitoring of renal function.
4. 8, proksimal tubulopati).
If serum phosphate is < 1.5 mg/ dl (0.48 mmol/ l) or creatinine clearance is decreased to < 50 ml/ min in any patient receiving Atripla, renal function must be re-evaluated within one week, including measurements of blood glucose, blood potassium and urine glucose concentrations (see section 4.8, proximal tubulopathy).
Da Atripla er et kombinationsprodukt og dosisintervallet for de enkelte komponenter ikke kan justeres, bør behandling med Atripla afbrydes hos patienter med bekræftet kreatininclearance < 50 ml/ min eller fald i serumphosphat til < 1, 0 mg/ dl (0, 32 mmol/ l).
Since Atripla is a combination product and the dosing interval of the individual components cannot be altered, treatment with Atripla must be interrupted in patients with confirmed creatinine clearance < 50 ml/ min or decreases in serum phosphate to < 1.0 mg/ dl (0.32 mmol/ l).
Hvis seponering af behandling med en af komponenterne i Atripla er indiceret, eller hvis dosismodificering er påkrævet, er separate efavirenz -, emtricitabin - og tenofovirdisoproxilfumarat- præparater tilgængelige.
Where discontinuation of therapy with one of the components of Atripla is indicated or where dose modification is necessary, separate preparations of efavirenz, emtricitabine and tenofovir disoproxil fumarate are available.
Der er indberettet mildt til moderat udslæt som følge af de individuelle Atripla - komponenter.
Skin reactions: mild-to-moderate rash has been reported with the individual components of Atripla.
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.
0, 1%.
The incidence of erythema multiforme or Stevens-Johnson syndrome was approximately 0.1%.
Patienter, hvis behandling med andre non- nukleosid- revers transkriptase- hæmmere seponeres på grund af udslæt, kan have højere risiko for at få udslæt under behandling med Atripla.
Patients who discontinued treatment with other non-nucleoside reverse transcriptase inhibitors due to rash may be at higher risk of developing rash during treatment with Atripla.
Antiretroviral kombinationsbehandling er hos HIV- patienter blevet associeret med omfordeling af kropsfedt (lipodystrofi).
Lipodystrophy and metabolic abnormalities: combination antiretroviral therapy has been associated with the redistribution of body fat (lipodystrophy) in HIV patients.
Det er blevet antaget, at der er en sammenhæng mellem visceral lipomatose og proteasehæmmere (PI) samt en
A connection between visceral lipomatosis and protease inhibitors (PI) and lipoatrophy and nucleoside reverse transcriptase inhibitors (NRTIs) has been hypothesised.
En højere risiko for lipodystrofi er associeret med individuelle faktorer som højere alder, og med lægemiddelrelaterede faktorer som 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.
5. 2) og kan føre til øget bivirkningsfrekvens (se pkt.
6 Effect of food: the administration of Atripla with food may increase efavirenz exposure (see section 5.2) and may lead to an increase in frequency of adverse reactions (see section 4.8).
Nukleosid - og nukleotidanaloger har vist sig at forårsage varierende grad af skade på mitokondrier in vitro og in vivo.
Mitochondrial dysfunction: nucleoside and nucleotide analogues have been demonstrated in vitro and in vivo to cause a variable degree of mitochondrial damage.
Der er rapporteret om mitokondriel dysfunktion hos HIV- negative spædbørn, som har været eksponeret for nukleosidanaloger in utero og/ eller postnatalt.
There have been reports of mitochondrial dysfunction in HIV negative infants exposed in utero and/ or postnatally to nucleoside analogues.
De hyppigst rapporterede uønskede hændelser er hæmatologiske forstyrrelser (anæmi, neutropeni), metaboliske forstyrrelser (hyperlaktatæmi, hyperlipasæmi).
The main adverse events reported are haematological disorders (anaemia, neutropenia), metabolic disorders (hyperlactataemia, hyperlipasaemia).
Nogle sent forekommende neurologiske forstyrrelser er blevet rapporteret (hypertoni, kramper, unormal adfærd).
Some late-onset neurological disorders have been reported (hypertonia, convulsion, abnormal behaviour).
I hvilken udstrækning disse neurologiske forstyrrelser er forbigående eller permanente er p. t. ikke kendt.
Whether the neurological disorders are transient or permanent is currently unknown.
Alle børn, der har været eksponeret for nukleosid - og nukleotidanaloger in utero, herunder også HIV- negative børn, bør følges klinisk og laboratoriemæssigt og udredes fuldstændigt for mulig mitokondriel dysfunktion i tilfælde af relevante tegn eller symptomer.
Any child exposed in utero to nucleoside and nucleotide analogues, even HIV negative children, should have clinical and laboratory follow-up and should be fully investigated for possible mitochondrial dysfunction in case of relevant signs or symptoms.
Disse resultater påvirker ikke de aktuelle nationale anbefalinger vedrørende brug af antiretroviral behandling hos gravide med henblik på at undgå vertikal HIV- overførsel.
These findings do not affect current national recommendations to use antiretroviral therapy in pregnant women to prevent vertical transmission of HIV.
Hos HIV- inficerede patienter med svær immuninsufficiens kan der ved initiering af antiretroviral kombinationsbehandling (CART) opstå en inflammatorisk reaktion på asymptomatiske eller residuale opportunistiske patogener, som kan forårsage alvorlige kliniske tilstande eller forværring af symptomer.
Immune Reactivation Syndrome: in HIV infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Relevante eksempler er cytomegalovirus retinitis, generaliserede og/ eller fokale mycobakterielle infektioner og pneumoni forårsaget af Pneumocystis jiroveci (tidligere kendt som Pneumocystis carinii).
Relevant examples are cytomegalovirus retinitis, generalised and/ or focal mycobacterial infections, and pneumonia caused by Pneumocystis jiroveci (formerly known as Pneumocystis carinii).
Ætiologien anses dog for at være multifaktoriel (omfattende anvendelse af kortikosteroider, alkoholforbrug, svær immunosuppression, højere Body Mass Index (BMI)).
Osteonecrosis: although the etiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV disease and/ or long term exposure to combination antiretroviral therapy (CART).
I en 144- ugers klinisk undersøgelse, som sammenlignede tenofovirdisoproxilfumarat 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.
Bone: in a 144-week controlled clinical study that compared tenofovir disoproxil fumarate 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.
Fald i knoglemineraltætheden i rygsøjlen samt ændringer i knoglebiomarkørerne fra baseline var signifikant større i tenofovirdisoproxilfumarat- behandlingsgruppen ved 144 uger.
Decreases in bone mineral density of spine and changes in bone biomarkers from baseline were significantly greater in the tenofovir disoproxil fumarate treatment group at 144 weeks.
Fald i knoglemineraltætheden i hoften var signifikant større i denne gruppe op til 96 uger.
Decreases in bone mineral density of the hip were significantly greater in this group until 96 weeks.
Der var imidlertid ingen øget risiko for frakturer eller tegn på klinisk relevante knogleabnormaliteter i løbet af de 144 uger.
However, there was no increased risk of fractures or evidence for clinically relevant bone abnormalities over 144 weeks.
Knogleabnormiteter (i sjældne tilfælde medvirkende årsag til frakturer) kan være forbundet med proximal renal tubulopati (se pkt.
Bone abnormalities (infrequently contributing to fractures) may be associated with proximal renal tubulopathy (see section 4.8).
Ved mistanke om knogleabnormaliteter, bør hensigtsmæssig rådgivning søges.
If bone abnormalities are suspected then appropriate consultation should be obtained.
Atriplas sikkerhed og virkning i kombination med andre antiretrovirale lægemidler er udokumenteret.
Other antiretroviral agents: no data are available on the safety and efficacy of Atripla in combination with other antiretroviral agents.
4. 5).
Didanosine: co-administration of Atripla and didanosine is not recommended since exposure to didanosine is significantly increased following co-administration with tenofovir disoproxil fumarate (see section 4.5).
Patienter med HIV- 1 med stammer som har mutationer:
Patients with HIV-1 harbouring mutations:
4. 1 og 5. 1).
Atripla should be avoided in patients with HIV-1 harbouring the K65R, M184V/ I or K103N mutation (see sections 4.1 and 5.1).