natgillin/translations-raw huggingface dataset:
H2-antagonister må kun tages en gang om dagen, hvis De tager Odefsey.
H2-antagonists can only be taken once a day if you take Odefsey.
Hvis De ved et uheld tager mere end den anbefalede dosis Odefsey, kan De have større risiko for at få bivirkninger med denne medicin (se punkt 4, Bivirkninger).
If you accidentally take more than the recommended dose of Odefsey you may be at increased risk of experiencing possible side effects with this medicine (see section 4, Possible side effects).
Det kan dog ikke udelukkes, at eksponering for farmakologisk aktiv, ubundet rilpivirin øges markant ved moderat nedsat funktion.
However, it may not be excluded that the pharmacologically active, unbound, rilpivirine exposure is significantly increased in moderate impairment.
Den kombination af NRTI'er, der hyppigst blev anvendt sammen med rilpivirin, var FTC/TDF (24 forsøgspersoner [66,7 %]).
The combination of NRTIs most frequently used together with rilpivirine was FTC/TDF (24 subjects [66.7%]).
• øget antal fedtsyrer (triglycerider), bilirubin eller lipase i blodet
• increased fatty acids (triglycerides), bilirubin or lipase in the blood
De farmakokinetiske data viser, at samlet eksponering (AUC) for rilpivirin som del af et antiretroviralt program var cirka 30 % lavere under graviditet sammenlignet med postpartum (6-12 uger).
The pharmacokinetic data demonstrate that total exposure (AUC) to rilpivirine as a part of an antiretroviral regimen was approximately 30% lower during pregnancy compared with postpartum (6-12 weeks).
Normalisering af alanintransaminase (ALAT) blev opnået hos 40 % (4/10) af forsøgspersoner med ALAT over den øvre normalgrænse (ULN) ved baseline.
Alanine aminotransferase (ALT) normalisation was achieved in 40% (4/10) of subjects with ALT greater than upper limit of normal (ULN) at baseline.
Tabel 6: Farmakokinetik for emtricitabin og tenofoviralafenamid hos antiretroviral-naive unge og voksne
Table 6: Pharmacokinetics of emtricitabine and tenofovir alafenamide in antiretroviral-naïve adolescents and adults
Induktion af P-gp
Induction of P-gp
Da rilpivirin er stærkt proteinbundet, er det usandsynligt, at dialyse i signifikant grad kan fjerne det aktive stof.
Since rilpivirine is highly protein bound, dialysis is unlikely to result in significant removal of the active substance.
Hos nogle patienter med fremskreden hiv-infektion (aids) og tidligere opportunistiske infektioner (infektioner, der forekommer hos personer med et svagt immunsystem) kan der forekomme tegn og symptomer på betændelse fra tidligere infektioner kort tid efter hiv-behandlingen startes.
In some patients with advanced HIV infection (AIDS) and a history of opportunistic infections (infections that occur in people with a weak immune system), signs and symptoms of inflammation from previous infections may occur soon after HIV treatment is started.
Rilpivirins terminale eliminationshalveringstid er ca. 45 timer.
The terminal elimination half-life of rilpivirine is approximately 45 hours.
Odefsey indeholder lactose
Odefsey contains lactose
Ændringer i lipidværdier i laboratorieprøver
Changes in lipid laboratory tests
Faldet i den ubundne frie fraktion ved eksponering for rilpivirin (dvs. aktiv) under graviditet sammenlignet med postpartum var mindre udtalt end for samlet eksponering for rilpivirin.
The decrease in the unbound free fraction of rilpivirine exposure (i.e., active) during pregnancy compared to postpartum was less pronounced than for total exposure of rilpivirine.
• tegn eller symptomer på betændelse eller infektion
• signs or symptoms of inflammation or infection
Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Odefsey i en eller flere undergrupper af den pædiatriske population ved behandlingen af human hiv 1-infektion (se pkt.
The European Medicines Agency has deferred the obligation to submit the results of studies with Odefsey in one or more subsets of the paediatric population in the treatment of human HIV-1 infection (see section 4.2 for information on paediatric use).
• et lavt antal hvide blodlegemer (et nedsat antal hvide blodlegemer kan gøre Dem mere modtagelig for infektioner)
• low white blood cell count (a reduced white blood cell count can make you more prone to infection)
• Hvis De er allergisk over for emtricitabin, rilpivirin, tenofoviralafenamid eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
• If you are allergic to emtricitabine, rilpivirine, tenofovir alafenamide or any of the other ingredients of this medicine (listed in section 6).
Kontakt lægen, før De tager Odefsey: • Hvis De har leverproblemer, eller hvis De tidligere har haft en leversygdom, herunder hepatitis (gulsot).
Talk to your doctor before taking Odefsey: • If you have liver problems or a history of liver disease, including hepatitis.
• Metadon, et lægemiddel der bruges til at behandle afhængighed af opiater, da det kan være nødvendigt for Deres læge at ændre metadondosis.
• Methadone, a medicine used to treat opiate addiction, as your doctor may need to change your methadone dose.
Samlede behandlingsresultater efter 48 uger vises i tabel 3.
Pooled treatment outcomes at 48 weeks are shown in Table 3.
Kombinationerne af emtricitabin, rilpivirin og tenofoviralafenamid var ikke antagonistiske og viste synergistiske virkninger med hinanden i kombinationsanalyser af antiviral aktivitet i cellekultur.
The combinations of emtricitabine, rilpivirine, and tenofovir alafenamide were not antagonistic and showed synergistic effects with each other in cell culture combination antiviral activity assays.
I et andet studie resulterede Y188L-substitution i en reduceret følsomhed over for rilpivirin på 9 gange for kliniske isolater og 6 gange for site-directed mutanter.
In another study, the Y188L substitution resulted in a reduced susceptibility to rilpivirine of 9-fold for clinical isolates and 6-fold for site-directed mutants.
Der blev kun påvist spormængder af uændret rilpivirin (< 1 % af dosis) i urin.
Only trace amounts of unchanged rilpivirine (< 1% of dose) were detected in urine.
Der blev set små forbedringer i BMD ved 48 uger efter skift til E/C/F/TAF sammenlignet med opretholdelse af regimet med tenofovirdisoproxilfumarat.
Small improvements in BMD were noted at 48 weeks after switching to E/C/F/TAF compared to maintaining the tenofovir disoproxil fumarate-containing regimen.
Odefsey [Kun på den ydre emballage]
Odefsey [Outer packaging only]
Forskellen i forekomst af nye virologiske svigt fra uge 48 til uge 96 var ikke statistisk signifikant mellem rilpivirin-armen og efavirenz-armen.
The difference in the rate of new virologic failures from the Week 48 to Week 96 analysis between rilpivirine and efavirenz arms was not statistically significant.
Lægemidler, der påvirker P-gp- og BCRP-aktiviteten, kan føre til ændringer i tenofoviralafenamids absorption (se tabel 1).
Medicinal products that affect P-gp and BCRP activity may lead to changes in tenofovir alafenamide absorption (see Table 1).
• Antibiotika, der anvendes til at behandle bakterieinfektioner, som indeholder:
• Antibiotics used to treat bacterial infections containing:
Nogle patienter, der tager antiretroviral kombinationsmedicin, såsom Odefsey, kan udvikle en knoglesygdom, der kaldes osteonekrose (knoglevævsdød forårsaget af manglende blodforsyning til knoglerne).
Some patients taking combination antiretroviral medicines such as Odefsey may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
Rilpivirin er ved den anbefalede dosis på 25 mg en gang om dagen ikke forbundet med en klinisk relevant indvirkning på QTc.
Rilpivirine at the recommended dose of 25 mg once daily is not associated with a clinically relevant effect on QTc.
Kvinder i den fertile alder/kontraception til mænd og kvinder Anvendelsen af Odefsey bør ledsages af anvendelse af sikker kontraception.
Women of childbearing potential/contraception in males and females The use of Odefsey should be accompanied by the use of effective contraception.
Tenofovir elimineres renalt, både ved glomerulær filtration og aktiv tubulær sekretion.
Tenofovir is renally eliminated by both glomerular filtration and active tubular secretion.
Rilpivirin hæmmer P-glycoprotein (P-gp) in vitro (50 % hæmningskoncentration [IC50] er 9,2 µM).
Rilpivirine inhibits P-glycoprotein (P-gp) in vitro (50% inhibitory concentration [IC50] is 9.2 µM).
Hæmning af CYP3A Forventet:
Induction of CYP3A Expected:
Den gennemsnitlige steady-state minimale plasmakoncentration 24 timer efter dosering var lig med eller større end den gennemsnitlige in vitro IC90-værdi for anti-hiv 1-aktivitet.
The mean steady-state plasma trough concentration at 24 hours post-dose was equal to or greater than the mean in vitro IC90 value for anti-HIV-1 activity.
• Dabigatranetexilat, et lægemiddel der bruges til at behandle hjertelidelser, da det kan være nødvendigt for Deres læge at overvåge niveauerne af dette lægemiddel i Deres blod.
• Dabigatran etexilate, a medicine used to treat heart conditions, as your doctor may need to monitor the levels of this medicine in your blood.
Meget hyppigt forekommende bivirkninger (alle grader) var hovedpine, depression, døsighed og kvalme.
Adverse reactions (all grades) of very common frequency were headache, depression, somnolence and nausea.
Virologisk supprimerede voksne i studiet GS-US-292-0109
Virologically suppressed adults in Study GS-US-292-0109
Ingen virologiske data ved uge 48- eller uge 144-vinduet Seponerede studiemedicin som følge af AE eller døde
No virologic data in Week 48 or 144 window Discontinued study drug due to AE or deathe
For monitorering af lipider og glucose i blodet henvises der til eksisterende retningslinjer om behandling af hiv.
For monitoring of blood lipids and glucose reference is made to established HIV treatment guidelines.
Pakningsstørrelser og yderligere oplysninger Odefsey indeholder:
Contents of the pack and other information What Odefsey contains
Tenofoviralafenamid transporteres af P-gp og brystcancer-resistensprotein (BCRP).
Tenofovir alafenamide is transported by P-gp and breast cancer resistance protein (BCRP).
• forhøjede niveauer af kolesterol og/eller pankreatisk amylase (et fordøjelsesenzym) i blodet
• increased levels of cholesterol and/or pancreatic amylase (a digestive enzyme) in the blood
K103N-substitutionen alene resulterede ikke i reduceret modtagelighed for rilpivirin, men kombinationen af K103N og L100I resulterede i en 7 gange reduceret følsomhed over for rilpivirin.
The K103N substitution alone did not result in reduced susceptibility to rilpivirine, but the combination of K103N and L100I resulted in a 7-fold reduced susceptibility to rilpivirine.
forhøjede transaminaser (ASAT og/eller ALAT)1
increased transaminases (AST and/or ALT)1
Der foreligger utilstrækkelige data for virkningen af alle indholdsstofferne i Odefsey hos nyfødte/spædbørn, og derfor bør Odefsey ikke bruges under amning.
There is insufficient information on the effects of all the components of Odefsey in newborns/infants, therefore Odefsey should not be used during breast-feeding.
Der foreligger ingen data om Odefseys virkning på menneskers fertilitet.
No human data on the effect of Odefsey on fertility are available.
Kun unge, der vurderes at kunne udvise compliance i forbindelse med antiretroviral terapi, bør behandles med rilpivirin, da suboptimal compliance kan føre til udvikling af resistens og tab af behandlingsmuligheder i fremtiden.
Only adolescents deemed likely to have good adherence to antiretroviral therapy should be treated with rilpivirine, as suboptimal adherence can lead to development of resistance and the loss of future treatment options.
Når De begynder med at tage Odefsey, skal De holde øje med:
Once you start taking Odefsey, look out for:
Emtricitabins biotransformation omfatter oxidation af thioldelen, hvorved der dannes 3'-sulfoxiddiastereomerer (cirka 9 % af dosen) og konjugering med glucuronsyre til at danne 2'-O-glucuronid (cirka 4 % af dosen).
The biotransformation of emtricitabine includes oxidation of the thiol moiety to form the 3'-sulfoxide diastereomers (approximately 9% of dose) and conjugation with glucuronic acid to form 2'-O-glucuronide (approximately 4% of dose).
nedsat appetit1, øget antal triglycerider (fastende)1
decreased appetite1, increased triglycerides (fasted)1
kvalme1,3, forhøjet pankreatisk amylase1
nausea1, 3, increased pancreatic amylase1
Odefsey er en grå, kapselformet, filmovertrukken tablet, som er præget med ”GSI” på den ene side og tallet ”255” på den anden side.
Odefsey is a grey, capsule-shaped, film-coated tablet debossed on one side with “GSI” and “255” on the other side.
a Uge 48-vinduet var fra dag 294 til 377 (inklusive), uge 144-vinduet var fra dag 966 til 1049 (inklusive).
a Week 48 window was between Day 294 and 377 (inclusive); Week 144 window was between Day 966 and 1,049 (inclusive).
Eksperimenter in vitro indikerer, at rilpivirinhydrochlorid primært undergår oxidativ metabolisme medieret af CYP3A-systemet.
In vitro experiments indicate that rilpivirine hydrochloride primarily undergoes oxidative metabolism mediated by the CYP3A system.
Hvis Odefsey stoppes uanset årsagen, skal De tale med Deres læge, før De igen begynder at tage Odefsey tabletter.
If Odefsey is stopped for any reason, speak to your doctor before you restart taking Odefsey tablets.
Interaktioner mellem Odefsey eller de individuelle indholdsstoffer i Odefsey og mulige samtidigt administrerede lægemidler ses i tabel 1 nedenfor (stigning er angivet som ”↑”, fald som ”↓”, ingen ændring som ”↔”).
Interactions between Odefsey or its individual component(s) and co-administered medicinal products are listed in Table 1 below (increase is indicated as “↑”, decrease as “↓” and no change as “↔”).
• rifabutin, rifampicin, rifapentin
• rifabutin, rifampicin, rifapentine
1 Bivirkninger identificeret i kliniske studier af rilpivirin.
1 Adverse reactions identified from rilpivirine clinical studies.
Som med andre antiretrovirale lægemidler bør resistenstest og/eller historiske resistensdata vejlede brugen af Odefsey (se pkt.
As with other antiretroviral medicinal products, resistance testing and/or historical resistance data should guide the use of Odefsey (see section 4.4).
Renal udskillelse af intakt tenofoviralafenamid er en mindre metaboliseringsvej med < 1 % af dosen elimineret i urinen.
Renal excretion of intact tenofovir alafenamide is a minor pathway with < 1% of the dose eliminated in urine.
Rilpivirin (en af komponenterne i Odefsey) i kombination med et baggrundsprogram evalueredes i studie TMC114HIV3015 hos 19 gravide kvinder i 2. og 3. trimester og postpartum.
Rilpivirine (one of the components of Odefsey) in combination with a background regimen was evaluated in Study TMC114HIV3015 in 19 pregnant women during the 2nd and 3rd trimesters, and postpartum.
86 % af patienterne (62/72) var HBV-supprimerede (HBV DNA < 29 IE/ml), og 42 % (30/72) var HBeAg-positive ved baseline.
Eighty-six percent of patients (62/72) were HBV suppressed (HBV DNA < 29 IU/mL) and 42% (30/72) were HBeAg positive at baseline.
Det er vigtigt ikke at komme til at springe en dosis af Odefsey over.
It is important not to miss a dose of Odefsey.
Op til 30 % af emtricitabindosis kan fjernes ved hæmodialyse.
Up to 30% of the emtricitabine dose can be removed by haemodialysis.
FTC = emtricitabin; TAF = tenofoviralafenamid; TFV = tenofovir, I/R = ikke relevant Data vises som gennemsnit (% CV).
FTC = emtricitabine; TAF = tenofovir alafenamide; TFV = tenofovir, N/A = not applicable Data are presented as mean (%CV).
Rilpivirin-resistente stammer blev udvalgt i cellekultur startende fra vildtype hiv 1 af forskellig oprindelse og undertyper samt NNRTI-resistent hiv 1.
Rilpivirine-resistant strains were selected in cell culture starting from wild-type HIV-1 of different origins and subtypes as well as NNRTI-resistant HIV-1.
De skal fortsætte med at være under lægens opsyn, mens De tager Odefsey.
You must remain under the care of your doctor while taking Odefsey.
• mavesmerter eller ubehag
• stomach pain or discomfort
Odefsey bruges til voksne og unge i alderen 12 år og ældre, der vejer mindst 35 kg.
Odefsey is used in adults and adolescents aged 12 years and older, who weigh at least 35 kg.
Behandlingsresultaterne i studierne GS-US-366-1216 og GS-US-366-1160 vises i tabel 5.
Treatment outcomes of Studies GS-US-366-1216 and GS-US-366-1160 are presented in Table 5.
Resistenstest og/eller historiske resistensdata bør vejlede brugen af Odefsey (se pkt.
Resistance testing and/or historical resistance data should guide the use of Odefsey (see section 5.1).
De samlede behandlingsresultater efter 48 og 144 uger vises i tabel 3.
Pooled treatment outcomes at 48 and 144 weeks are shown in Table 3.
Ved starten af behandlingen med E/C/F/TAF havde 72 patienter været hiv-supprimerede (hiv-1 RNA < 50 kopier/ml) i mindst 6 måneder med eller uden supprimering af HBV DNA, og de havde kompenseret leverfunktion.
At the start of treatment with E/C/F/TAF, the 72 patients had been HIV suppressed (HIV-1 RNA < 50 copies/mL) for at least 6 months with or without suppression of HBV DNA and had compensated liver function.
Andelen af patienter med hiv 1-rna < 50 kopier/ml ved uge 48 (TLOVR) var 72,2 % (26/36).
The proportion of patients with HIV-1 RNA < 50 copies/mL at Week 48 (TLOVR) was 72.2% (26/36).
Patienterne bør informeres om, at der er rapporteret om træthed, svimmelhed og søvnighed under behandling med indholdsstofferne i Odefsey (se pkt.
Patients should be informed that fatigue, dizziness and somnolence have been reported during treatment with the components of Odefsey (see section 4.8).
Dosisanbefalingerne gælder for den anbefalede dosis af rilpivirin på 25 mg en gang dagligt.
The dosing recommendation is applicable to the recommended dose of rilpivirine of 25 mg once daily.
Hos patienter med svært nedsat nyrefunktion eller nyresygdom i sidste stadie kan plasmakoncentrationer være forhøjede på grund af ændret absorption, distribution og/eller metabolisme af lægemidler som følge af renal dysfunktion.
In patients with severe renal impairment or end-stage renal disease, plasma concentrations may be increased due to alteration of drug absorption, distribution and/or metabolism secondary to renal dysfunction.
Risikoen for stigninger i plasmakoncentrationerne af dabigatran kan ikke udelukkes (hæmning af intestinal P-gp).
A risk for increases in dabigatran plasma concentrations cannot be excluded (inhibition of intestinal P-gp).
Titandioxid (E171) Jernoxid, sort (E172)
Titanium dioxide (E171) Iron oxide black (E172)
Tegn på osteonekrose er: stivhed i led smerter i led (især i hofter, knæ og skuldre) bevægelsesbesvær
Signs of osteonecrosis are: joint stiffness joint aches and pains (especially of the hip, knee and shoulder) difficulty with movement
Odefsey skal anvendes med forsigtighed hos patienter med moderat nedsat leverfunktion.
Odefsey should be used with caution in patients with moderate hepatic impairment.
I et studie, der sammenlignede 8 patienter med let nedsat leverfunktion (Child-Pugh-klasse A) med 8 matchede kontroller og 8 patienter med moderat nedsat leverfunktion (Child-Pugh-klasse B) med 8 matchede kontroller, var flerdosis eksponering for rilpivirin 47 % højere hos patienter med let nedsat leverfunktion og 5 % højere hos patienter med moderat nedsat leverfunktion.
In a study comparing 8 patients with mild hepatic impairment (Child-Pugh Class A) to 8 matched controls and 8 patients with moderate hepatic impairment (Child-Pugh Class B) to 8 matched controls, the multiple dose exposure of rilpivirine was 47% higher in patients with mild hepatic impairment and 5% higher in patients with moderate hepatic impairment.
På baggrund af lægemiddelinteraktionsstudier udført med Odefseys indholdsstoffer forventes der ingen klinisk signifikante interaktioner, når Odefsey kombineres med følgende lægemidler: buprenorphin, naloxon og norbuprenorphin.
Studies conducted with other medicinal products Based on drug-drug interaction studies conducted with the components of Odefsey, no clinically significant interactions are expected when Odefsey is combined with the following medicinal products: buprenorphine, naloxone and norbuprenorphine.
I dette studie svarede sikkerhedsprofilen for unge patienter til den for voksne (se pkt.
In this study, the safety profile in adolescent patients was similar to that in adults (see section 5.1).
I/R 10,0 (19,6)
N/A 10.0 (19.6)
Hold ikke op med at tage Odefsey Hold ikke op med at tage Odefsey uden at tale med Deres læge.
Do not stop taking Odefsey Do not stop taking Odefsey without talking to your doctor.
Odefsey fås i tabletbeholdere med 30 tabletter samt i pakninger med 3 tabletbeholdere hver med 30 tabletter.
Odefsey comes in bottles of 30 tablets and in packs made up of 3 bottles, each containing 30 tablets.
Ved supraterapeutiske doser (75 mg en gang om dagen og 300 mg en gang om dagen) er rilpivirin blevet forbundet med forlængelse af QTc-intervallet i elektrokardiogrammet (EKG) (se pkt.
At supratherapeutic doses (75 mg once daily and 300 mg once daily), rilpivirine has been associated with prolongation of the QTc interval of the electrocardiogram (ECG) (see sections 4.5 and 4.9).
Filmovertræk: Macrogol, polyvinylalkohol, talcum, titandioxid (E171), jernoxid, sort (E172).
Film-coating: Macrogol, polyvinyl alcohol, talc, titanium dioxide (E171), iron oxide black (E172).
Patienter, som får Odefsey, har fortsat risiko for opportunistiske infektioner eller andre hiv-relaterede komplikationer, og bør derfor følges nøje af læger med erfaring i behandlingen af patienter med hiv-associerede sygdomme.
Patients receiving Odefsey 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.
Unge i alderen 12 år og ældre, som vejer mindst 35 kg: en tablet om dagen sammen med mad Tabletten må ikke tygges, knuses eller deles.
Adolescents 12 years of age and older, who weigh at least 35 kg: one tablet each day with food Do not chew, crush or split the tablet.
Der bør kun anvendes H2receptorantagonister, som kan doseres en gang dagligt.
Only H2-receptor antagonists that can be dosed once daily should be used.
a n = 24 unge (GS-US-292-0106), n = 19 voksne (GS-US-292-0102).
a n = 24 adolescents (GS-US-292-0106); n = 19 adults (GS-US-292-0102).
Sent forekommende neurologiske forstyrrelser er blevet rapporteret i sjældne tilfælde (hypertoni, kramper, unormal adfærd).
Late onset neurological disorders have been reported rarely (hypertonia, convulsion, abnormal behaviour).
Brug af anden medicin sammen med Odefsey Fortæl altid lægen eller apotekspersonalet, hvis De tager anden medicin eller har gjort det for nylig.
Other medicines and Odefsey Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Børn og unge Denne medicin må ikke gives til børn i alderen 11 år eller derunder eller børn, som vejer under
Children and adolescents Do not give this medicine to children aged 11 years or under, or weighing less than 35 kg.
K65R- og også K70E-substitution resulterer i nedsat følsomhed for abacavir, didanosin, lamivudin, emtricitabin og tenofovir, men de bevarer følsomhed for zidovudin.
The K65R and also the K70E substitution result in reduced susceptibility to abacavir, didanosine, lamivudine, emtricitabine, and tenofovir, but retain sensitivity to zidovudine.
Rilpivirinhydrochlorid metaboliseres og elimineres primært i leveren.
Rilpivirine hydrochloride is primarily metabolised and eliminated by the liver.
Interaktion er ikke blevet undersøgt med nogen af Odefseys indholdsstoffer.
Interaction not studied with any of the components of Odefsey.
Rilpivirin er en diarylpyrimidin NNRTI af hiv 1.
Rilpivirine is a diarylpyrimidine NNRTI of HIV-1.
For en sikkerheds skyld bør anvendelse af Odefsey under graviditet undgås.
As a precautionary measure, it is preferable to avoid the use of Odefsey during pregnancy.