FrancophonIA/ELRC3.0 huggingface dataset:
English: Administration of up to 1,200 mg emtricitabine has been associated with the adverse reactions listed above (see section 4.8).
Danish: Administration af op til 1.200 mg emtricitabin er blevet forbundet med ovenstående bivirkninger (se pkt.
English: Pharmacokinetic parameters were determined following administration of a single dose of 200 mg emtricitabine hard capsules to 30 non-HIV infected subjects with varying degrees of renal insufficiency.
Danish: Farmakokinetiske parametre blev bestemt efter administration af en enkelt dosis af 200 mg emtricitabin hårde kapsler til 30 ikke-hiv-inficerede forsøgspersoner med forskellige grader af nyreinsufficiens.
English: It is important not to miss a dose of Emtriva.
Danish: Det er vigtigt, at De husker at tage hver dosis af Emtriva.
English: The safety and efficacy of the dose interval adjustments to every 72 or 96 hours in patients with creatinine clearance < 30 mL/min have not been clinically evaluated.
Danish: Sikkerheden og virkningen ved justering af dosisintervallet til hver 72. eller 96. time hos patienter med kreatininclearance < 30 ml/min er ikke blevet evalueret klinisk.
English: The biotransformation of emtricitabine includes oxidation of the thiol moiety to form the 3'-sulphoxide diastereomers (approximately 9% of dose) and conjugation with glucuronic acid to form 2'-O-glucuronide (approximately 4% of dose).
Danish: Emtricitabins biotransformation omfatter oxidation af thiolandelen til at danne 3'-sulfoxid-diastereomere (ca. 9% af dosen) og forbindelse med glukuronsyre til at danne 2'-O-glukuronid (ca. 4 % af dosen).
English: If you have a history of liver disease or chronic hepatitis B infection your doctor may conduct blood tests in order to carefully monitor liver function.
Danish: Hvis De tidligere har haft en leversygdom eller en kronisk hepatitis B-infektion, vil Deres læge muligvis tage blodprøver for nøje at overvåge leverfunktionen.
English: Such exacerbations have been seen following discontinuation of emtricitabine treatment in HBV infected patients without concomitant HIV infection and have been detected primarily by serum alanine aminotransferase (ALT) elevations in addition to re-emergence of HBV DNA.
Danish: Sådanne eksacerbationer er set efter emtricitabinbehandlingens ophør hos HBV-inficerede patienter uden ledsagende hiv-infektion og er blevet påvist primært ved stigninger i serum-alanin-aminotransferase (ALAT) samt fremkomst af HBV-dna igen.
English: What you need to know before you take Emtriva Do not take Emtriva
Danish: Det skal De vide, før De begynder at tage Emtriva Tag ikke Emtriva
English: In a pilot study in children and a definitive bioequivalence study in adults, the Emtriva 10 mg/mL oral solution was shown to have approximately 80% of the bioavailability of the Emtriva 200 mg hard capsules.
Danish: I en pilotstudier med børn og en definitiv bioækvivalensstudier med voksne viste Emtriva 10 mg/ml oral opløsning sig at have ca. 80% af biotilgængeligheden af Emtriva 200 mg hårde kapsler.
English: Therapy should be initiated by a physician experienced in the management of HIV infection.
Danish: Behandlingen skal initieres af en læge med erfaring i behandlingen af hiv-infektion.
English: In the adult studies, 1,039 treatment-naïve and 440 treatment-experienced patients received emtricitabine (n = 814) or comparator medicinal product (n = 665) for 48 weeks in combination with other antiretroviral medicinal products.
Danish: I studierne med voksne fik 1.039 behandlingsnaive og 440 behandlingserfarne patienter emtricitabin (n = 814) eller et referencepræparat (n = 665) i 48 uger i kombination med andre antiretrovirale lægemidler.
English: Emtricitabine did not inhibit the enzyme responsible for glucuronidation.
Danish: Emtricitabin hæmmede ikke det enzym, som er ansvarligt for glukuronidation.
English: • Infants, children and adolescents weighing 40 kg or less: the dose of Emtriva 10 mg/mL oral solution is calculated according to your body weight.
Danish: • Børn og unge, som vejer 40 kg eller derunder: Emtriva 10 mg/ml oral opløsning doseres i henhold til legemsvægt.
English: This medicine also contains 480 mg propylene glycol per 24 mL (maximum single dose) which is equivalent to a maximum of 12 mg/kg/day.
Danish: Dette lægemiddel indeholder også 480 mg propylenglycol pr. 24 ml (maksimal enkeltdosis), svarende til højst 12 mg/kg/dag.
English: For infants from 4 months, children, and patients who are unable to swallow hard capsules and patients with kidney problems, Emtriva is available as a liquid (an oral solution).
Danish: Til børn over 4 måneder og patienter, som ikke kan synke hårde kapsler og til patienter med nyreproblemer, kan Emtriva fås i flydende form (en oral opløsning).
English: This medicinal product contains 36 mg of sodium per 24 mL, equivalent to 1.8% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Danish: Dette lægemiddel indeholder 36 mg natrium pr. 24 ml, svarende til 1,8 % af den WHO anbefalede maksimale daglige indtagelse af 2 g natrium for en voksen.
English: elevated serum aspartate aminotransferase (AST) and/or elevated serum ALT, hyperbilirubinaemia
Danish: forhøjet serum-aspartat-aminotransferase (ASAT) og/eller forhøjet serum-ALAT, hyperbilirubinæmi
English: The pharmacokinetics of emtricitabine have not been studied in non-HBV infected subjects with varying degrees of hepatic insufficiency.
Danish: Emtricitabins farmakokinetik er ikke blevet undersøgt hos ikke-HBV-inficerede forsøgspersoner med forskellige grader af leverinsufficiens.
English: 30 hard capsules.
Danish: 30 hårde kapsler.
English: There are no clinically significant interactions when emtricitabine is co-administered with indinavir, zidovudine, stavudine, famciclovir or tenofovir disoproxil fumarate.
Danish: Der foreligger ingen klinisk signifikante interaktioner, når emtricitabin indgives samtidig med indinavir, zidovudin, stavudin, famciclovir eller tenofovirdisoproxilfumarat.
English: Indigotine (E132) Titanium dioxide (E171)
Danish: Indigotin (E132) Titandioxid (E171)
English: The blood levels obtained after taking one Emtriva 200 mg hard capsule are similar to those obtained after taking 24 mL of the oral solution.
Danish: Blodniveauerne, som opnås efter at have taget én Emtriva 200 mg hård kapsel, svarer til dem, som opnås efter at have taget 24 ml af den orale opløsning.
English: Also, emtricitabine did not inhibit uridine-5'-diphosphoglucuronyl transferase, the enzyme responsible for glucuronidation.
Danish: Endvidere hæmmede emtricitabin ikke uridin-5'-diphosphoglukuronyl-transferase, det enzym, som er ansvarlig for glukuronidation.
English: However, based on the minimal metabolism of emtricitabine and the renal route of elimination it is unlikely that a dose adjustment would be required in patients with hepatic insufficiency (see section 5.2).
Danish: Baseret på den minimale metabolisme af emtricitabin og eliminationsvejen gennem nyrerne, er det dog usandsynligt, at en dosisjustering ville være nødvendig hos patienter med leverinsufficiens (se pkt.
English: The pharmacokinetics of emtricitabine are proportional to dose over the dose range of 25-200 mg following single or repeated administration.
Danish: Emtricitabins farmakokinetik er proportional med dosen over dosisområdet 25-200 mg efter en eller flere administrationer.
English: The recommended dose is: • Adults: one 200 mg hard capsule, each day with or without food.
Danish: Den anbefalede dosis er: • Voksne: Én 200 mg hård kapsel dagligt med eller uden mad.
English: With the exception of famciclovir and tenofovir disoproxil fumarate, the effect of co-administration of emtricitabine with medicinal products that are excreted by the renal route, or other medicinal products known to affect renal function, has not been evaluated.
Danish: Bortset fra famciclovir og tenofovirdisoproxilfumerat, er virkningen af samtidig administration af emtricitabin og lægemidler, der udskilles gennem nyrerne eller andre lægemidler, som vides at påvirke nyrefunktionen, ikke blevet evalueret.
English: • Children and adolescents up to 18 years of age who weigh at least 33 kg and who are able to swallow hard capsules: one 200 mg hard capsule, each day with or without food.
Danish: • Børn og unge under 18 år, som vejer mindst 33 kg og som kan synke hårde kapsler: Én 200 mg hård kapsel dagligt med eller uden mad.
English: In infants and children older than 4 months, the majority of patients achieved or maintained complete suppression of plasma HIV-1 RNA through 48 weeks (89% achieved ≤ 400 copies/mL and 77% achieved ≤ 50 copies/mL).
Danish: Hos børn, der var over 4 måneder gamle, opnåede eller opretholdt størstedelen af patienterne komplet suppression af plasma hiv 1-rna igennem 48 uger (89% opnåede ≤ 400 kopier/ml og 77% opnåede ≤ 50 kopier/ml).
English: Emtriva comes in bottles or blister packs containing 30 capsules.
Danish: Emtriva fås i beholdere eller blisterpakninger, som indeholder 30 kapsler.
English: Emtriva oral solution can be taken with or without food.
Danish: Emtriva oral opløsning kan tages med eller uden mad.
English: Emtricitabine is rapidly and extensively absorbed following oral administration with peak plasma concentrations occurring at 1 to 2 hours post-dose.
Danish: Efter oral administration absorberes emtricitabin hurtigt og omfattende, hvor peakplasmakoncentrationer opnås 1-2 timer efter dosering.
English: The safety and efficacy of the reduced doses provided in section 4.2 are based on single dose pharmacokinetic data and modelling and have not been clinically evaluated.
Danish: Sikkerheden og virkningen af de i pkt 4.2 anførte reducerede doser er baseret på farmakokinetiske data og modellering ved en enkelt dosis og er ikke blevet klinisk evalueret.
English: No data are available on which to make a dose recommendation in paediatric patients with renal insufficiency.
Danish: Der foreligger ingen data, der gør det muligt at give en dosisanbefaling til pædiatriske patienter med nyreinsufficiens.
English: Sunset yellow (E110) may cause allergic reactions.
Danish: Sunset yellow FCF (E110) kan give allergiske reaktioner.
English: There is no experience of the use of emtricitabine in patients who are failing their current regimen or who have failed multiple regimens.
Danish: Der er ingen erfaring med anvendelsen af emtricitabin hos patienter, hvis nuværende regime har været uden virkning eller hvor flere regimer har været uden virkning.
English: The bottle contains 170 mL of solution.
Danish: Flasken indeholder 170 ml oral opløsning.
English: Patients with renal insufficiency can also be managed by administration of Emtriva 10 mg/mL oral solution to provide a reduced daily dose of emtricitabine.
Danish: Patienter med nyreinsufficiens kan også behandles ved administration af Emtriva 10 mg/ml oral opløsning for at give en reduceret daglig dosis af emtricitabin.
English: Emtricitabine is phosphorylated by cellular enzymes to form emtricitabine 5'-triphosphate, which competitively inhibits HIV-1 reverse transcriptase, resulting in DNA chain termination.
Danish: Emtricitabin phosphoryleres af celleenzymer til at danne emtricitabin 5'-triphosphat, som kompetitivt hæmmer hiv 1 reverse transkriptase, som resulterer i dna-kædeterminering.
English: High density polyethylene (HDPE) bottle with a polypropylene child-resistant closure, containing 30 hard capsules.
Danish: Beholder af højdensitetspolyethylen (HDPE) med børnesikret lukke af polypropylen indeholdende 30 hårde kapsler.
English: Emtricitabine-resistant viruses were cross-resistant to lamivudine, but retained sensitivity to other nucleoside reverse transcriptase inhibitors (NRTIs) (zidovudine, stavudine, tenofovir, abacavir and didanosine), all non-nucleoside reverse transcriptase inhibitors (NNRTIs) and all PIs.
Danish: Emtricitabin-resistente virus var krydsresistente over for lamivudin, men beholdt følsomhed over for andre nukleosid reverse transkriptasehæmmere (Nucleoside Reverse Transcriptase Inhibitors, NRTIs) (zidovudin, stavudin, tenofovir, abacavir og didanosin), alle non-nukleoside reverse transkriptasehæmmere (Non-Nucleoside Reverse Transcriptase Inhibitors, NNRTIs) og alle PI'er.
English: If you accidentally take too many Emtriva hard capsules, contact your doctor or nearest emergency department for advice.
Danish: Hvis De ved et uheld tager for mange Emtriva hårde kapsler, skal De kontakte lægen eller den nærmeste skadestue for at få råd.
English: Consequently, either a dose interval adjustment (using Emtriva 200 mg hard capsules) or a reduction in the daily dose of emtricitabine (using Emtriva 10 mg/mL oral solution) is required in all patients with creatinine clearance < 30 mL/min.
Danish: Derfor er enten en justering af dosisintervallet (med Emtriva 200 mg hårde kapsler) eller en reduktion i den daglige dosis af emtricitabin (med Emtriva 10 mg/ml oral opløsning) nødvendig hos alle patienter med kreatininclearance < 30 ml/min.
English: Amber-coloured polyethylene terephthalate (PET) bottle with a child-resistant closure.
Danish: Gulbrun flaske af polyethylenterephthalat (PET) med børnesikret lukke.
English: Plasma emtricitabine exposure (AUC) in infants up to 3 months of age who received 3 mg/kg emtricitabine once daily was similar to that observed using 6 mg/kg daily doses in HIV infected adults and children aged 4 months and over.
Danish: Emtricitabins eksponering i plasma (AUC) hos børn på op til 3 måneder, der fik behandling med 3 mg/kg emtricitabin én gang dagligt, var på det samme niveau som det, der blev observeret ved brug af 6 mg/kg daglig dosis hos hiv-inficerede voksne og børn, der var 4 måneder og ældre.
English: Emtricitabine in combination with other antiretroviral agents, including nucleoside analogues, non-nucleoside analogues and PIs, has been shown to be effective in the treatment of HIV infection in treatment-naïve patients and treatment-experienced patients with stable virological control.
Danish: Emtricitabin i kombination med andre antiretrovirale midler, herunder nukleosidanaloger, non-nukleosidanaloger og PI'er har vist sig at være effektive ved behandlingen af hiv-infektion hos behandlingsnaive patienter og behandlingserfarne patienter med stabil, virologisk kontrol.
English: As a general rule, it is recommended that HIV infected women do not breast-feed their infants under any circumstances 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 under ingen omstændigheder ammer deres børn.
English: The use of emtricitabine may be considered during pregnancy, if necessary.
Danish: Hvis det er indiceret, kan anvendelse af emtricitabin overvejes under graviditet.
English: Assessment of adverse reactions from clinical study data is based on experience in three studies in adults (n = 1,479) and three paediatric studies (n = 169).
Danish: Vurderingen af bivirkningsdata fra kliniske studier er baseret på erfaringer fra tre studier med voksne (n = 1.479) og tre pædiatriske studier (n = 169).
English: Do not use this medicine after the expiry date which is stated on the bottle, blister pack and carton after “EXP”.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på beholderen, blisterpakningen og kartonen efter „EXP“.
English: • anaemia (low red blood cell count)
Danish: • lavt antal af røde blodlegemer (anæmi)
English: Emtriva 200 mg hard capsules are available for adults, adolescents and children who weigh at least 33 kg and can swallow hard capsules.
Danish: Emtriva 200 mg hårde kapsler kan fås til voksne, unge mennesker og børn, som vejer mindst 33 kg, og kan sluge hårde kapsler.
English: In 20 HIV infected subjects receiving 200 mg emtricitabine daily as hard capsules, steady-state plasma emtricitabine peak concentrations (Cmax), trough concentrations (Cmin) and area under the plasma concentration time curve over a 24-hour dosing interval (AUC) were 1.8 ± 0.7 µg/mL, 0.09 ± 0.07 µg/mL and 10.0 ± 3.1 µg·h/mL, respectively.
Danish: Hos 20 hiv-inficerede forsøgspersoner, som fik 200 mg emtricitabin daglig som hårde kapsler, var de maksimale steady-state emtricitabinkoncentrationer (Cmax) i plasma, de minimale koncentrationer (Cmin) og området under plasmakoncentrationens tidskurve over et 24-timers doseringsinterval (AUC) henholdsvis 1,8 ± 0,7 µg/ml, 0,09 ± 0,07 µg/ml og 10,0 ± 3,1 µg·t/ml.
English: Blood and lymphatic system disorders: Common:
Danish: Blod og lymfesystem: Almindelig:
English: hypertriglyceridaemia, hyperglycaemia
Danish: hypertriglyceridæmi, hyperglykæmi
English: Mechanism of action and pharmacodynamic effects Emtricitabine is a synthetic nucleoside analogue of cytidine with activity that is specific to HIV-1, HIV-2and HBV.
Danish: Virkningsmekanisme og farmakodynamisk virkning Emtricitabin er en syntetisk nukleosidanalog af cytidin med aktivitet, som er specifik mod hiv 1, hiv 2 og HBV.
English: Capsule shell Gelatin
Danish: Kapslens skal Gelatine
English: Emtricitabine is primarily excreted via glomerular filtration and active tubular secretion.
Danish: Emtricitabin udskilles primært ved glomerulusfiltration og aktiv tubulær sekretion.
English: Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
Danish: Nogle af de patienter, der får flere slags antiretroviral medicin på samme tid, kan udvikle en knoglesygdom, der kaldes knoglenekrose (hvor knoglevævet dør på grund af nedsat blodtilførsel til knoglen).
English: Emtricitabine exposure may be markedly increased in patients with severe renal insufficiency (creatinine clearance < 30 mL/min) receiving daily doses of 200 mg emtricitabine as hard capsules or 240 mg as the oral solution.
Danish: Emtricitabineksponering kan stige markant hos patienter med svær nyreinsufficiens (kreatininclearance < 30 ml/min), som får daglige doser af 200 mg emtricitabin som hårde kapsler eller 240 mg som oral opløsning.
English: Subjects were grouped according to baseline creatinine clearance (> 80 mL/min as normal function; 50-80 mL/min as mild impairment; 30-49 mL/min as moderate impairment; < 30 mL/min as severe impairment; < 15 mL/min as functionally anephric requiring haemodialysis).
Danish: Forsøgspersoner blev grupperet i henhold til kreatininclearance ved baselinie (> 80 ml/min som normal nyrefunktion; 50-80 ml/min som mildt nedsat nyrefunktion; 30-49 ml/min som moderat nedsat nyrefunktion; < 30 ml/min som svært nedsat nyrefunktion; < 15 ml/min som svigt af nyrefunktion med behov for hæmodialyse).
English: Emtriva is also available as an oral solution for use in children and infants aged 4 months and over, patients who have difficulty in swallowing and patients with kidney problems.
Danish: Emtriva kan også fås som oral opløsning til anvendelse hos børn på 4 måneder og derover, patienter, som har problemer med at synke, og patienter med nyreproblemer.
English: There is no experience of the use of Emtriva in patients who are failing their current regimen or who have failed multiple regimens (see section 5.1).
Danish: Der er ingen erfaring med anvendelsen af Emtriva hos patienter, hvis nuværende regime har været uden virkning eller, hvor flere regimer har været uden virkning (se pkt.
English: Tell your doctor immediately about new or unusual symptoms after you stop treatment, particularly symptoms you associate with hepatitis B infection.
Danish: Bemærker De nogle nye eller usædvanlige symptomer efter behandlingens ophør, skal De omgående oplyse Deres læge herom, især hvis det drejer sig om symptomer, som De normalt ville forbinde med hepatitis B-infektion.
English: Emtriva 200 mg hard capsules are only suitable for patients who weigh at least 33 kg. Emtriva oral solution is available for people who have difficulty in swallowing Emtriva hard capsules.
Danish: Emtriva 200 mg hårde kapsler er kun egnede til patienter, som vejer mindst 33 kg. Emtriva kan fås som oral opløsning til patienter, der har problemer med at synke Emtriva hårde kapsler.
English: At 48 weeks of treatment the emtricitabine-containing regimen demonstrated an equivalent proportion of patients with HIV RNA < 400 copies/mL (94% emtricitabine versus 92%) and a greater proportion of patients with HIV RNA < 50 copies/mL (95% emtricitabine versus 87%) compared with the patients continuing with their PI-HAART regimen.
Danish: Efter 48 ugers behandling viste regimet med emtricitabin en tilsvarende procentdel af patienter med hiv-rna < 400 kopier/ml (94% emtricitabin versus 92%) og en større procentdel af patienter med hiv-rna < 50 kopier/ml (95% emtricitabin versus 87%) sammenlignet med de patienter, som fortsatte med deres PI-HAART regime.
English: In patients with ESRD on haemodialysis, approximately 30% of the emtricitabine dose was recovered in dialysate over a 3 hour dialysis period which had been started within 1.5 hours of emtricitabine dosing (blood flow rate of 400 mL/min and dialysate flow rate of approximately 600 mL/min).
Danish: Hos patienter med ESRD med behov for hæmodialyse, blev ca. 30% af emtricitabindosen genfundet i dialysat over en 3-timers dialyseperiode, som var blevet startet inden for 1,5 time efter emtricitabindosering (blodgennemstrømningshastighed på 400 ml/min og dialysatgennemstrømningshastighed på ca. 600 ml/min).
English: • If you have both HIV infection and hepatitis B, it is especially important not to stop your
Danish: • Hvis De har både hiv-infektion og hepatitis B, er det særlig vigtigt ikke at ophøre med behandlingen med Emtriva uden først at tale med Deres læge.
English: Adults: The recommended dose of Emtriva is one 200 mg hard capsule, taken orally, once daily.
Danish: Voksne: Den anbefalede dosis af Emtriva er én 200 mg hård kapsel, taget oralt, en gang daglig.
English: In general, the pharmacokinetics of emtricitabine in infants, children and adolescents (aged 4 months up to 18 years) are similar to those seen in adults.
Danish: Pædiatrisk population Generelt er emtricitabins farmakokinetik hos børn og unge (fra 4 måneder til 18 år) som hos voksne.
English: In combination studies of emtricitabine with protease inhibitors (PIs), nucleoside, nucleotide and non-nucleoside analogue inhibitors of HIV reverse transcriptase, additive to synergistic effects were observed.
Danish: I kombinationsstudier af emtricitabin med proteasehæmmere (PI'er), nukleosid, nukleotid og non-nukleoside analoghæmmere af hiv-reverse transkriptase, desuden oberserveredes virkninger fra additiv til synergetisk.
English: Other medicines and Emtriva
Danish: Brug af anden medicin sammen med Emtriva
English: Emtricitabine is principally eliminated by the kidney via glomerular filtration and active tubular secretion.
Danish: Emtricitabin elimineres primært gennem nyrerne ved glomerulusfiltration og aktiv tubulær sekretion.
English: Patients with renal insufficiency can also be managed by administration of Emtriva 200 mg hard capsules at modified dose intervals.
Danish: Patienter med nyreinsufficiens kan også behandles ved administration af Emtriva 200 mg hårde kapsler med ændrede dosisintervaller.
English: Emtriva is also available as a 10 mg/mL oral solution for use in infants aged 4 months and over, children and patients who are unable to swallow hard capsules and patients with renal insufficiency.
Danish: Emtriva kan også fås som en 10 mg/ml oral opløsning til anvendelse hos børn på 4 måneder og derover, børn og patienter, som ikke kan synke hårde kapsler, og til patienter med nyreinsufficiens.
English: Administration of Emtriva 200 mg hard capsules with a high-fat meal or administration of Emtriva 10 mg/mL oral solution with a low-fat or high-fat meal did not affect systemic exposure (AUC0-∞) of emtricitabine; therefore Emtriva 200 mg hard capsules and Emtriva 10 mg/mL oral solution may be administered with or without food.
Danish: Indtagelse af Emtriva 200 mg hårde kapsler sammen med et måltid med højt fedtindhold eller indtagelse af Emtriva 10 mg/ml oral opløsning sammen med et måltid med lavt eller højt fedtindhold påvirkede ikke emtricitabins systemiske eksponering (AUC0-∞); derfor kan Emtriva 200 mg hårde kapsler og Emtriva 10 mg/ml oral opløsning indtages med eller uden mad.