FrancophonIA/ELRC3.0 huggingface dataset:
English: If any antiretroviral medicinal product in a combination regimen is interrupted because of suspected intolerance, serious consideration should be given to simultaneous discontinuation of all antiretroviral medicinal products.
Danish: Hvis et eller flere antiretrovirale lægemidler i et kombinationsregime afbrydes på grund af mistanke om intolerance, skal samtidig seponering af alle antiretrovirale lægemidler alvorligt overvejes.
English: Efavirenz may remain in your blood for a time after therapy is stopped.
Danish: Efavirenz kan blive i blodet et stykke tid efter, at behandlingen er stoppet.
English: In particular, severe depression was more common in those with a history of depression.
Danish: Specielt var alvorlig depression mere hyppig hos patienter med depression i anamnesen.
English: Antibiotics
Danish: Antibiotika
English: Concomitant use of posaconazole and efavirenz should be avoided unless the benefit to the patient outweighs the risk.
Danish: Samtidig anvendelse af posaconazol og efavirenz bør undgås medmindre fordelen for patienten opvejer risikoen.
English: rare photoallergic dermatitis
Danish: Fotoallergisk dermatit
English: The net effect of coadministration is not clear.
Danish: Nettoeffekten ved samtidig administration er ikke klarlagt.
English: Cardiac Electrophysiology
Danish: Kardiologisk elektrofysiologi
English: Since no dose recommendation for itraconazole can be made, alternative antifungal treatment should be considered.
Danish: Da dosisrekommandation for itraconazol ikke kan gives, bør alternativ antimykotisk behandling overvejes.
English: No dose adjustment is necessary for efavirenz when given with indinavir or indinavir/ritonavir.
Danish: Dosisjustering er ikke nødvendig for efavirenz, når det gives sammen med indinavir eller indinavir/ritonavir.
English: Efavirenz must not be used as a single agent to treat HIV or added on as a sole agent to a failing regimen.
Danish: Efavirenz må ikke bruges som eneste lægemiddel til behandling af hiv eller som eneste lægemiddel føjes til et svigtende regime.
English: Patients and caregivers must be instructed to open the capsule carefully to avoid spillage or dispersion of the capsule contents into the air.
Danish: Patienter og plejere skal instrueres i at åbne kapslen forsigtigt for at undgå spild eller spredning af kapslens indhold til luften.
English: 1 Avoid giving the daily SUSTIVA dose within 1 hour after a feeding or meal.
Danish: 1Undgå at give den daglige dosis SUSTIVA inden for 1 time efter et måltid.
English: UNIQUE IDENTIFIED - HUMAN READABLE DATA
Danish: ENTYDIG IDENTIFIKATOR - MENNESKELIGT LÆSBARE DATA
English: Verapamil, Felodipine, Nifedipine and Nicardipine
Danish: Verapamil, felodipin, nifedipin og nicardipin
English: Norbuprenorphine:
Danish: Norbuprenorphin:
English: What SUSTIVA contains
Danish: SUSTIVA indeholder
English: Taking into account the PRAC Assessment Report on the PSUR(s) for efavirenz, the scientific conclusions of CHMP are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om PSUR'en/PSUR'erne for efavirenz er CHMP nået frem til følgende videnskabelige konklusioner:
English: The antiretroviral medicinal products should be restarted at the same time upon resolution of the intolerance symptoms.
Danish: De antiretrovirale lægemidler skal reintroduceres på samme tid, efter symptomerne på intolerance er forsvundet.
English: The capsules must be opened carefully so that the contents do not spill or escape into the air.
Danish: Kapslerne skal åbnes forsigtigt, for at indholdet ikke spildes eller slipper ud i luften.
English: Table 1: Paediatric dose to be administered once daily*
Danish: Tabel 1: Pædiatisk dosis til indgivelse én gang dagligt*
English: 15 Do not give the child any additional food for 2 hours.
Danish: 15 Giv ikke barnet andet mad i 2 timer.
English: c C.I., confidence interval for proportion of patients in response.
Danish: C.I., konfidensinterval for antal patienter med respons d
English: The dose for children and adolescents is calculated by body weight and is taken once daily as shown below:
Danish: Dosis til børn og unge beregnes efter legemsvægt og tages 1 gang dagligt som vist nedenfor:
English: If you are taking any of these medicines, your doctor may need to check the level of anticonvulsant medicine in your blood to ensure that it is not affected while taking SUSTIVA.
Danish: Hvis De får noget af denne medicin, kan det være nødvendigt, at lægen kontrollerer mængden af denne medicin i Deres blod for at sikre, at denne ikke påvirkes af, at De tager SUSTIVA.
English: If you have taken SUSTIVA or the combination tablet containing efavirenz, emtricitabine, and tenofovir during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child.
Danish: Hvis De har taget SUSTIVA eller kombinationstabletten med efavirenz, emtricitabin og tenofovir under graviditeten, kan lægen bede om regelmæssige blodprøver og andre diagnostiske prøver for at kontrollere barnets udvikling.
English: Try not to miss a dose.
Danish: Forsøg at undgå at springe en dosis over.
English: The incidence of neural tube defects in the general population ranges from 0.5-1 case per 1,000 live births.
Danish: Incidensen af neuralrørsdefekt i befolkningen generelt er 0,5-1 tilfælde pr. 1.000 levendefødsler.
English: There were insufficient data to determine whether moderate or severe hepatic impairment (Child-Pugh Class B or C) affects efavirenz pharmacokinetics.
Danish: Der var ikke tilstrækkelige data til at afgøre, om moderat eller svær leverinsufficiens (Child Pugh klasse B eller C) påvirker efavirenz' farmakokinetik.
English: UNIQUE IDENTIFIED - 2D BARCODE Outer carton: 2D barcode carrying the unique identifier included.
Danish: ENTYDIG IDENTIFIKATOR - 2D-STREGKODE Ydre pakning: Der er anført en 2D-stregkode, som indeholder en entydig identifikator.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Danish: Hvis De af Deres læge har fået at vide, at der er visse sukkerarter, De ikke kan tåle, skal De kontakte lægen, før De tager dette lægemiddel.
English: Metabolic parameters
Danish: Metaboliske parametre
English: - severe depression - suicidal ideation - non-fatal suicide attempts - aggressive behaviour - paranoid reactions - manic reactions
Danish: - Svær depression - Suicidale tanker - Ikke- dødelige selvmordsforsøg - Aggresiv adfærd - Paranoide reaktioner - Maniske reaktioner
English: In view of the data presented in the reviewed PSUR, the overall risk-benefit balance of efavirenz is therefore considered unchanged in the approved indications provided that the terms of the marketing authorisation are varied as relevant.
Danish: I lyset af de data, der er fremlagt i den reviderede PSUR, anses det overordnede benefit/risk-forhold for efavirenz derfor for at være uændret i de godkendte indikationer under forudsætning af, at betingelserne for markedsføringstilladelsen ændres som relevant.
English: This may stop the medicines from working properly, or may make any side effects worse.
Danish: Dette kan forhindre, at medicinen virker, som den skal, eller forværre eventuelle bivirkninger.
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and pneumonia caused by Pneumocystis jiroveci (formerly known as Pneumocystis carinii).
Danish: Relevante eksempler er cytomegalovirus retinitis, generaliserede og/eller fokale mycobakterielle infektioner og pneumoni fremkaldt af pneumocystis jiroveci (tidligere kendt som pneumocystis carinii).
English: The mixture should be administered as soon as possible, but no more than 30 minutes after mixing.
Danish: Blandingen skal gives så hurtigt som muligt, og ikke mere end 30 min. efter opblandingen.
English: Efavirenz was not mutagenic or clastogenic in conventional genotoxicity assays.
Danish: Efavirenz var ikke mutagent eller klastogent i konventionelle genotoksicitetsbestemmelser.
English: Despite the decrease in buprenorphine exposure, no patients exhibited withdrawal symptoms.
Danish: På trods af faldet i buprenorphineksponering udviste ingen patienter abstinenssymptomer.
English: You must not take SUSTIVA with certain medicines.
Danish: De må ikke tage SUSTIVA sammen med visse former for medicin.
English: Your doctor may conduct blood tests in order to check how well your liver is working or may switch you to another medicine.
Danish: Lægen vil måske tage blodprøver for at kontrollere, hvor godt Deres lever virker eller måske skifte Dem til anden medicin.
English: 13 Stir to make sure there is no drug residue remaining in the container (illustration e).
Danish: 13 Bland godt og sørg for, at der ikke er nogen medicinrester tilbage i skålen (illustration e).
English: Patients should be informed that if they do occur, these common symptoms are likely to improve with continued therapy and are not predictive of subsequent onset of any of the less frequent psychiatric symptoms.
Danish: Patienterne bør informeres om, at disse almindelige bivirkninger sandsynligvis bedres ved fortsat behandling, og at de ikke er indikatorer for, at der efterfølgende vil opstå nogle af de mindre hyppige psykiatriske symptomer.
English: Efavirenz is a NNRTI of HIV-1.
Danish: Efavirenz er en NNRTIer af hiv-1.
English: No dose adjustment is necessary for raltegravir.
Danish: Dosisjustering er ikke nødvendig for raltegravir.
English: 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 and indinavir.
Danish: Selvom den kliniske betydning af nedsat indinavirkoncentration ikke er fastslået, bør omfanget af den observerede farmakokinetiske interaktion tages i betragtning, når der vælges et regime, der både indeholder efavirenz og indinavir.
English: Since efavirenz is highly protein bound, dialysis is unlikely to remove significant quantities of it from blood.
Danish: Da efavirenz har en høj proteinbindingsgrad, er det usandsynligt, at dialyse vil fjerne signifikante mængder af det fra blodet.
English: As neural tube defects occur within the first 4 weeks of foetal development (at which time neural tubes are sealed), this potential risk would concern women exposed to efavirenz during the first trimester of pregnancy.
Danish: Da neuralrørsdefekter forekommer inden for de første 4 uger af fosterudviklingen (hvor de neurale rør lukkes), vedrører denne potentielle risiko kvinder, der eksponeres for efavirenz i graviditetens første trimester.
English: There is no specific antidote for overdose with efavirenz.
Danish: Der findes ingen specifik antidot mod overdosering med efavirenz.
English: In a single-dose study, half life was doubled in the single patient with severe hepatic impairment (Child Pugh Class C), indicating a potential for a much greater degree of accumulation.
Danish: I en undersøgelse med enkeltdosering blev halveringstiden fordoblet hos den enkelte patient med svær leverinsufficiens (Child Pugh klasse C), hvilket indikerer en risiko for en langt større grad af akkumulering.
English: Based on this new data, the PRAC considers that the statement that the interaction between etonogestrel and efavirenz has not been studied is no longer valid and that this statement should be removed from the SmPC of all efavirenz-containing products.
Danish: Baseret på disse nye data anser PRAC udsagnet om, at interaktionen mellem etonogestrel og efavirenz ikke er blevet undersøgt, for ikke at være gyldigt længere, og PRAC finder, at dette udsagn skal fjernes fra produktresuméet for alle produkter indeholdende efavirenz.
English: QTc Prolongation
Danish: Forlænget QTc-interval
English: Patients with: - a family history of sudden death or of congenital prolongation of the QTc interval on electrocardiograms, or with any other clinical condition known to prolong the QTc interval.
Danish: Patienter med: - pludseligt dødsfald eller medfødt forlængelse af QTc-intervallet på elektrokardiogrammer i familien eller med alle andre kliniske tilstande, som vides at forlænge QTc-intervallet.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Danish: Yderligere oplysninger om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: Rosuvastatin is largely excreted unchanged via the faeces, therefore interaction with efavirenz is not expected.
Danish: Rosuvastatin udskilles i stor udstrækning uændret via fæces, interaktion med efavirenz forventes derfor ikke.
English: Ketoconazole and other imidazole antifungals
Danish: Ketoconazol og andre imidazolantimykotika
English: Autoimmune disorders may occur many months after the start of treatment.
Danish: Autoimmune lidelser kan opstå mange måneder efter, De er påbegyndt behandling.
English: Consider alternatives to efavirenz for coadministration with a drug with a known risk of Torsade de Pointes or when to be administered to patients at higher risk of Torsade de Pointes.
Danish: Overvej alternativer til efavirenz, når dette administreres sammen med et lægemiddel med kendt risiko for torsade de pointes, eller når det administreres til patienter med høj risiko for at få torsade de pointes.
English: Analysis of long-term data showed that, beyond 24 weeks of therapy, the incidences of new-onset nervous system symptoms among efavirenz-treated patients were generally similar to those in the control arm.
Danish: Analyse af langtidsdata viste, at efter 24 ugers behandling var hyppigheden af nye symptomer fra nervesystemet hos efavirenzbehandlede patienter generelt den samme som i kontrolgruppen.
English: Dark yellow, capsule-shaped, printed with “SUSTIVA” on both sides.
Danish: Mørkegule, kapselformede, præget med “SUSTIVA” på begge sider.
English: A positive relationship between efavirenz concentration and QTc prolongation was observed.
Danish: Der var et positivt forhold mellem koncentrationen af efavirenz og forlængelsen af QTc-intervallet.
English: See also ritonavir row above.
Danish: Se også ritonavir ovenfor.
English: Method of administration
Danish: Administrationsmetode
English: Medicines used to lower blood fats (also called statins): atorvastatin, pravastatin, simvastatin.
Danish: Medicin til at mindske fedt i blodet (også kaldet statiner): atorvastatin, pravastatin, simvastatin.
English: If you do miss a dose, take the next dose as soon as possible, but do not take a double dose to make up for a forgotten dose.
Danish: Hvis De kommer til at springe en dosis over, skal De tage den næste dosis så hurtigt som muligt, men De må ikke fordoble den næste dosis.
English: if you have a history of liver disease, including active chronic hepatitis.
Danish: - hvis De tidligere har haft leversygdom, herunder aktiv kronisk hepatitis.
English: bone problems.
Danish: knogleproblemer.
English: While the carcinogenic potential in humans is unknown, these data suggest that the clinical benefit of efavirenz outweighs the potential carcinogenic risk to humans.
Danish: Selvom carcinogenicitetspotentialet hos mennesker ikke er kendt, antyder disse data, at efavirenz' kliniske fordele opvejer den mulige carcinogenicitet hos mennesker.
English: One child was reported to have a neural tube defect, and the frequency and pattern of other birth defects were similar to those seen in children exposed to non-efavirenz-containing regimens, as well as those in HIV negative controls.
Danish: Der blev rapporteret om ét barn med neuralrørsdefekt, og frekvensen og mønsteret for andre fødselsdefekter var de samme som hos børn, der havde været eksponeret for regimer uden efavirenz samt hos hiv-negative kontroller.
English: The dose for SUSTIVA may need to be increased or decreased if you are also taking certain medicines (see Other medicines and SUSTIVA).
Danish: Det kan blive nødvendigt at øge eller nedsætte SUSTIVA dosis, hvis De også tager anden medicin (se Brug af anden medicin sammen med SUSTIVA).
English: Thirteen isolates previously characterised as efavirenz-resistant were also resistant to nevirapine and delavirdine.
Danish: 13 isolater, der tidligere var beskrevet som efavirenzresistente, var også resistente over for nevirapin og delavirdin.
English: Therapy should be initiated by a physician experienced in the management of HIV infection.
Danish: Behandlingen bør initieres af læger med erfaring i behandling af hiv-infektion.
English: There is insufficient information on the effects of efavirenz in newborns/infants.
Danish: Der foreligger utilstrækkelige data for virkningen af efavirenz hos nyfødte/spædbørn.
English: No malformations were observed in foetuses from efavirenz-treated rats and rabbits.
Danish: Der sås ingen misdannelser hos fostre fra efavirenzbehandlede rotter og kaniner.
English: In a study of uninfected volunteers, a representative nervous system symptom had a median time to onset of 1 hour post-dose and a median duration of 3 hours.
Danish: I en undersøgelse med ikke-inficerede frivillige forsøgspersoner var der for et repræsentativt symptom fra nervesystemet en mediantid indtil debut på 1 time efter dosering og en medianvarighed på 3 timer.
English: Your doctor will give you instructions for proper dosing.
Danish: Deres læge vil informere Dem om den rette dosering.
English: Intermittent monotherapy and sequential reintroduction of antiretroviral agents is not advisable because of the increased potential for selection of resistant virus.
Danish: Intermitterende monoterapi og sekventiel reintroduktion af antiretrovirale lægemidler kan ikke tilrådes på grund af forøget risiko for selektion af resistent virus.
English: Once you start taking SUSTIVA, look out for:
Danish: Når De er startet med Sustiva, skal De være opmærksom på:
English: Carbamazepine may make SUSTIVA less likely to work.
Danish: Carbamazepin kan bevirke, at SUSTIVA virker dårligere.
English: For a summary of clinical and pharmacodynamic information, see section 5.1.
Danish: For et resumé af kliniske og farmakodynamiske oplysninger se pkt.
English: SUSTIVA should never be used alone to treat HIV.
Danish: SUSTIVA må aldrig anvendes alene til behandling af HIV.
English: Confirmatory testing by a more specific method such as gas chromatography/mass spectrometry is recommended in such cases.
Danish: I sådanne tilfælde anbefales det at udføre bekræftende analyser ved en mere specifik metode, såsom gaskromatografi/massespektrometri.
English: *,†,‡ See section Description of selected adverse reactions for more details.
Danish: †,‡ Se punktet Beskrivelse af udvalgte bivirkninger for yderligere information.
English: Efavirenz has a relatively long terminal half-life of at least 52 hours after single doses and 4055 hours after multiple doses.
Danish: Efavirenz har en forholdsvis lang halveringstid på mindst 52 timer efter enkeltdoser og 40 - 55 timer efter multiple doser.
English: The daily dose of rifabutin should be increased by 50% when administered with efavirenz.
Danish: Den daglige dosis rifabutin bør øges med 50%, når det administreres sammen med efavirenz.
English: A third isolate which carried a substitution at position 236 of RT was not cross-resistant to efavirenz.
Danish: Et tredje isolat, som var bærer af en substitution på position 236 af RT, var ikke krydsresistent over for efavirenz.
English: Substantial decrease in lopinavir exposure.
Danish: Væsentligt fald i lopinavireksponering.
English: In the analysis of responder rates (the non-completer equals failure analysis [NC = F]), patients who terminated the study early for any reason, or who had a missing HIV-RNA measurement that was either preceded or followed by a measurement above the limit of assay quantification were considered to have HIV-RNA above 50 or above 400 copies/ml at the missing time points.
Danish: I analysen af responsraten (non-completer lig med failure analysen [NC = F]), blev patienter, der udgik af studiet tidligt uanset grund, patienter som manglede en hivRNA måling, som enten var forudgået eller blev efterfulgt af en måling over assaygrænsen, formodet at have hiv-RNA over 50 eller over 400 kopier/ml på de manglende tidspunkter.
English: Patients taking drugs that are known to prolong the QTc interval (proarrythmic).
Danish: Patienter der tager lægemidler, som vides at forlænge QTc-intervallet (proarytmisk).
English: Some patients accidentally taking 600 mg twice daily have reported increased nervous system symptoms.
Danish: Nogle patienter, der ved et uheld har taget 600 mg 2 gange dagligt, har rapporteret forøgede symptomer fra nervesystemet.
English: Other medicines and SUSTIVA
Danish: Brug af anden medicin og SUSTIVA
English: HDPE bottles with a child-resistant polypropylene closure.
Danish: HDPE-flasker med børnesikret polypropylenlåg.
English: Biliary fibrosis has been observed in rats.
Danish: Der er set biliær fibrose hos rotter.
English: Buprenorphine/naloxone/Efavirenz Buprenorphine: AUC: ↓ 50%
Danish: Buprenorphin/naloxon/efavirenz Buprenorphin: AUC: ↓ 50%
English: Contraindications of concomitant use
Danish: Kontraindikationer ved samtidig brug
English: The methadone dose was increased by a mean of 22% to alleviate withdrawal symptoms.
Danish: Methadondosis øgedes med gennemsnitligt 22% for at mildne abstinenssymptomerne.
English: Efavirenz induced foetal resorptions in rats.
Danish: Efavirenz inducerede føtal resorption hos rotter.
English: Mean change from baseline-CD4 cell count
Danish: Middelændring fra baseline-CD4 celletal
English: The single substitutions which led to the highest resistance to efavirenz in cell culture correspond to a leucine-to-isoleucine change at position 100 (L100I, 17 to 22-fold resistance) and a lysine-to-asparagine at position 103 (K103N, 18 to 33-fold resistance).
Danish: De enkelte substitutioner, der resulterede i den største resistens over for efavirenz ved cellekultur, svarer til en leucin-til-isoleucin forandring på position 100 (L100I, 17 til 22 gange så stor resistens) og en lysin-til-asparagin på position 103 (K103N, 18 til 33 gange så stor resistens).
English: Refer to the Summary of Product Characteristics for the medicinal product containing maraviroc.
Danish: Se produktresuméet for lægemiddel indeholdende maraviroc.
English: Patients with mild liver disease may be treated with their normally recommended dose of efavirenz.
Danish: Patienter med mild leversygdom kan behandles med den normalt anbefalede dosis efavirenz.
English: See also ritonavir row below.
Danish: Se også ritonavir nedenfor.
English: Although cross-resistance of efavirenz with PIs has not been documented, there are at present insufficient data on the efficacy of subsequent use of PI based combination therapy after failure of regimens containing SUSTIVA.
Danish: Selvom der ikke er dokumenteret krydsresistens mellem efavirenz og PI´ere, er der i øjeblikket ikke tilstrækkelige data med hensyn til effekten af efterfølgende brug af PI-baseret kombinationsbehandling efter svigtende effekt af regimer, der inkluderer SUSTIVA.
English: Use of efavirenz in combination with saquinavir as the sole protease inhibitor is not recommended.
Danish: Brug af efavirenz sammen med saquinavir som eneste proteasehæmmer anbefales ikke.
English: Discuss with your doctor the precautions needed to avoid infecting other people.
Danish: Tal med lægen om forholdsregler for at undgå at smitte andre mennesker.
English: In the long-term study (006), 1% of patients in each treatment arm discontinued because of liver or biliary system disorders.
Danish: I langtidsundersøgelsen (006) afbrød 1% af patienterne i hver af behandlingsarmene behandlingen pga. problemer fra lever eller galdeveje.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 28 May 1999
Danish: Dato for første tilladelse: 28. maj 1999